Drug lookup, recalls and shortages

Metoprolol Tartrate Tablets

Advagen Pharma Limited

Why: Presence of Foreign Tablets/Capsules

Class II: could cause temporary or reversible harm

About 14.6 million people in the US are prescribed metoprolol each year.

Physitemp Ret-1 Rectal Probe Model/Catalog Number: Ret-1 and Physitemp Eso-1 for Esophageal and General Purpose Use Ref: Eso-1 . and 8 more (10 items)

Physitemp Instruments

Why: Temperature monitors and associated probes have not been reviewed for safety and effectiveness for intended use.

Class II: could cause temporary or reversible harm

Medline Convenience Kits Containing Bd Urinary Catheter Trays That Include Clini (10 items)

Medline Industries

Why: Convenience kits contain additional product codes and lots of recalled CliniClean Pericare Wipes identified by manufacturer. Wipes may be contaminated with a lubricant used in the manufacturing process. Use of affected...

Class II: could cause temporary or reversible harm

Eleganz Fusion Screw System (2 items)

Dev4

Why: Driver bit included in fusion Screw System may fracture or break during use resulting in intraoperative delay.

Class II: could cause temporary or reversible harm

Country Creek Acres Alfalfa Sprout Seeds Packed in A Clear and Silver Poly Bag

Country Creek

Why: Products contain seed recalled from the supplier and may be contaminated with E. coli and/or Salmonella

Class I: could cause serious harm or death

Cold Smoked Sprats

D & M Smoked Fish

Why: May be contaminated with Clostridium botulinum

Class I: could cause serious harm or death

Alfalfa Sprouts Hydroponically Grown.

Francisco Family Foods

Why: Potential E. coli and Salmonella contamination

Class I: could cause serious harm or death

Ams

Boston Scientific

Why: Potential for the Rear Tip Extender (RTE) size contained within the package to differ from the size identified on the product labeling. Certain packages labeled as containing a 0.5 cm RTE may contain a 1.5 cm RTE.

Class II: could cause temporary or reversible harm

Straumann Blc Implants and Straumann Healing Abutments (2 items)

Straumann USA

Why: Potential exposure to contamination, possibly compromising the sterility and cleanliness.

Class II: could cause temporary or reversible harm

Umary Acido Hialuronico

Ibeautistore.Com

Why: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.

Not Yet Classified

Cardinal Health Presource Pbds Kits (2 items)

Cardinal Health 200

Why: Notification of performance disclosures of kit component.

Class I: could cause serious harm or death

Lisdexamfetamine Dimesylate Capsules

Sun Pharmaceutical Industries

Why: Failed Dissolution Specifications

Class II: could cause temporary or reversible harm

About 1.6 million people in the US are prescribed lisdexamfetamine each year.

Vesco Q Enteral Feeding Pump and Vesco Q and 1 more (7 items)

Vesco Medical

Why: The feeding pump may deliver enteral fluids outside its labeled accuracy specification of +/-5%. This inaccuracy can result in over-delivery or under-delivery of enteral fluids relative to the prescribed dose, if proper...

Class II: could cause temporary or reversible harm

Orl Organic Oral Care Bubblegum Kids Natural Toothpaste and Orl Organic Oral Care Cinnamint Toothpaste and 4 more (6 products)

Orl Labs

Why: Cross-contamination: The firm was notified by the FDA of sampling results which found the presence of progesterone, estradiol, or dehydroepiandrosterone (DHEA)

Class II: could cause temporary or reversible harm

Raw Milk Cheddar Cheese Packed in Vacuum Sealed Clear Plastic with A White

Family Farmstead Dairy

Why: Potential contamination with E. coli (pathogenic non-O157 STEC).

Class I: could cause serious harm or death

Gore¿ Viabahn¿ Endoprosthesis with Heparin Bioactive Surface

W L Gore & Associates

Why: Endovascular prosthesis were manufactured on equipment that was not operating with valid parameters and may cause the distal tip to separate.

Class II: could cause temporary or reversible harm

Zynex Medical M-Wave

Altivera Medical

Why: Muscle stimulator may deliver constant electrical impulses to all four electrodes simultaneously, instead of alternating between the electrodes as designed, which may cause muscle fatigue.

Class II: could cause temporary or reversible harm

Philips Allura Xper Systems with Software Releases R8.1.X and R8.2.X Systems and

Philips Medical Systems Nederland B.V.

Why: Software issue that may cause the FlexVision software application to become unresponsive during clinical use.

Class II: could cause temporary or reversible harm

Acuson Orgin Ultrasound Imaging System Ref: and Acuson Orgin Ice Ultrasound Imaging System Ref: and 2 more (4 items)

Siemens Medical Solutions USA

Why: A software issue identified in the ultrasound system may result in the unintended activation of the Color Doppler setting, which has not received FDA clearance. This unintended activation could cause the system to crash...

Class II: could cause temporary or reversible harm

Tcd Electrodes

Boston Scientific Neuromodulation

Why: Radiofrequency probes may have small cut marks on the Tyvek side of the sterile pouch, and if the sterile barrier is compromised and devices are used, this could cause microbial or other foreign material contamination...

Class II: could cause temporary or reversible harm

Carelink Smartsync Device Manager App and Programmer and 1 more (3 items)

Medtronic

Why: Bluetooth disconnections may occur between the device manager software and its associated accessories. Bluetooth disconnections during a SmartSync patient session may lead to harm due to undesirable or incomplete...

Class II: could cause temporary or reversible harm

Artis Icono Biplane. Model Number: and Artis Icono Ceiling. Model Number: and 2 more (4 items)

Siemens Medical Solutions USA

Why: Potential that the system may not execute movement control commands as intended and may display the following message to the user, "Limited stand/table movement, SC."

Class II: could cause temporary or reversible harm

Atellica Ch Hdl Cholesterol and Atellica Ch Total Protein_2 (2 items)

Siemens Healthcare Diagnostics

Why: Reagent probe carryover on the Atellica CH and Atellica CI Analyzers may cause falsely elevated Hemoglobin A1c (A1c_E/A1c_H) results due to HDLC carryover (biases of 9 29% in NGSP units), and falsely depressed Direct...

Class II: could cause temporary or reversible harm

Ocs Heart Perfusion Set Model/Catalog Number: and Ocs Liver Perfusion Set Model/Catalog Number: and 1 more (3 items)

Transmedics

Why: The Perfusion Module may have an unprogrammed Front End Board (FEB) which will not allow the system to proceed beyond the initial startup process. The OCS system will display an error message saying Unsupported...

Class II: could cause temporary or reversible harm

Ocs Liver Perfusion Set Model/Catalog Number:

Transmedics

Why: Incorrectly assembled device sets with incorrect accessories.

Class II: could cause temporary or reversible harm

Ocs Heart System Ocs Heart Perfusion Set Model/Catalog Number: and Ocs Liver System Ocs Liver Perfusion Set Model/Catalog Number: and 1 more (3 items)

Transmedics

Why: Incorrectly assembled device kits that include incorrect components.

Class II: could cause temporary or reversible harm

Sheehy Ventilation Tube and Bobbin Ventilation Tube (2 items)

Medtronic Xomed

Why: Ventilation tubes, that provide a passageway for movement of air between the auditory canal and the middle ear, were not subjected to the required sterilization process, which after implantation could cause infection...

Class II: could cause temporary or reversible harm

Ocs Liver System for Organ Transport Ocs Liver Perfusion Set Model/Catalog Numbe and Ocs Liver System for Organ Transport Ocs Liver Solution Infusion Set Model/Catal and 1 more (3 items)

Transmedics

Why: Faulty Solution Delivery System (SDS) Cassettes within the device set were assembled with syringes that were manufactured with an atypical lubricant, which results in sub-par performance and has the potential to cause...

Class II: could cause temporary or reversible harm

Halyard Arthroscopy Pack. Model/Catalog Number: Samm014-21.

Avid Medical

Why: Shelf label of kit is mislabeled as "Extremity" instead of "Arthroscopy Pack."

Class II: could cause temporary or reversible harm

Liaison Plex Gram-Negative Blood Culture Assay Catalog No.

Luminex

Why: Instructions for Use updated to include explicit guidance that repeat testing is recommended whenever a positive family-level only result is obtained. Issue may contribute to incorrect or delayed diagnosis of...

Class II: could cause temporary or reversible harm

Wise Wife Ground Cinnamon in Plastic Container with Black Screw Top Cap

Slr Food Distribution

Why: Product contains elevated levels of lead

Not Yet Classified

365 Whole Foods Market Standardized + Full Spectrum Blend Ashwagandha Capsules

Vitality Works

Why: Possible Salmonella contamination.

Not Yet Classified

Olmesartan Medoxomil Amlodipine and Hydrochlorothiazide

Macleods Pharma USA, sold nationwide

Olmesartan medoxomil/amlodipine/hydrochlorothiazide tablets, 40 mg/10 mg/12.5mg, in 30-count and 90-count bottles, were recalled because they may not dissolve as required, so the body may absorb less drug than intended. Lots 12251163A and 12251163B, both expiring 05-31-2027, were sold nationwide in the USA.

FDA reason: Failed Dissolution Specifications.

Class II: could cause temporary or reversible harm

In the news: 19 news outlets mentioned olmesartan in recall stories in the last two weeks.

About 18.4 million people in the US are prescribed amlodipine each year.

Valuhealth Extra Strength Pain Relief Acetaminophen

Prodose, sold nationwide

ValuHealth acetaminophen 500 mg, 40-caplet bottles, was recalled because the bottle label says Pain Relief PM instead of acetaminophen. Lot P260252, exp. 4/30/2029, was distributed nationwide in the USA.

FDA reason: Incorrect label placed on product: Outer carton label correctly identifies drug product in bottle as ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg,but inner label on bottle says ValuHealth Extra Strength...

Class III: unlikely to cause harm

In the news: 11 news outlets mentioned acetaminophen in recall stories in the last two weeks.

About 6.5 million people in the US are prescribed acetaminophen each year.

Atorvastatin Calcium

Msn Laboratories Private Limited (Formulations Division, Unit-Ii), sold nationwide

Why: Presence of Foreign Tablets/Capsules

Class II: could cause temporary or reversible harm

About 29.7 million people in the US are prescribed atorvastatin each year.

Formoterol Fumarate Dihydrate

the Ritedose, sold nationwide

Why: Failed Impurities/Degradation Specification

Class II: could cause temporary or reversible harm

About 1.9 million people in the US are prescribed formoterol each year.

Wechem Hand Guard8/1000ml Bag and Lynx and 15 more (19 products)

Abc Compounding Co., sold nationwide

Why: CGMP Deviations

Class II: could cause temporary or reversible harm

Metoclopramide

Safecor Health, sold nationwide

Why: Manufacturer is recalling batches due to co-mingled tablet.

Class II: could cause temporary or reversible harm

About 590,000 people in the US are prescribed metoclopramide each year.

Lidocaine Ointment USP

Direct Rx, sold nationwide

Why: Subpotent Drug

Class II: could cause temporary or reversible harm

About 610,000 people in the US are prescribed lidocaine each year.

Automated Impella Controller and Impella Optical Controller and 1 more (3 items)

Abiomed, sold nationwide

Why: Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge...

Class I: could cause serious harm or death

Electric Medicated Balm Ultra Strength

Fei Fah Medical Manufacturing Pte., sold nationwide

Why: CGMP Deviations

Class II: could cause temporary or reversible harm

Carboxymethylcellulose Sodium

Huons Co., sold nationwide

Why: Failed Impurities/Degradation Specification; detection of polyethylene (PE)-related oligomers

Class II: could cause temporary or reversible harm

Lidocaine

Trifluent Pharma

Why: Labeling: Incorrect or Missing Lot and/or Exp Date. Incorrect expiration date printed on the label.

Not Yet Classified

About 610,000 people in the US are prescribed lidocaine each year.

Philips Azurion and Philips Azurion S. Model Number: (9 items)

Philips Medical Systems Nederland B.V., sold nationwide

Why: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over...

Class II: could cause temporary or reversible harm

Pentax Medical Ultrasound Endoscope. Model Numbers. Eg-3870utk and Pentax Medical Water Bottle Assembly. Model Number. Os-H5. and 3 more (5 items)

Pentax of America, sold nationwide

Why: Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.

Class II: could cause temporary or reversible harm

Vecuronium Bromide (2 products)

Meitheal Pharmaceuticals, sold nationwide

Why: Labeling: Label Lacks Warning or Rx Legend

Class III: unlikely to cause harm

Theophylline Extended-Release Tablets (2 products)

Brandywine Pharmaceuticals, sold nationwide

Why: CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory

Class II: could cause temporary or reversible harm

Phenylephrine HCL Infusion and Oxytocin (2 products)

Eagle Pharma Outsourcing, sold nationwide

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

Abiraterone Acetate

Glenmark Pharmaceuticals Inc., USA, sold nationwide

Why: Labeling: Not Elsewhere Classified

Class II: could cause temporary or reversible harm

Omniasecure Model

Medtronic, sold nationwide

Why: Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty.

Class II: could cause temporary or reversible harm

Alphenix Interventional Angiography System Ref: Infx-8000f and Alphenix Interventional Angiography System Ref: Infx-8000c and 1 more (3 items)

Canon Medical System, USA, sold nationwide

Why: Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.

Class II: could cause temporary or reversible harm

Carelink Smartsync Programmer and Carelink Smartsync and 1 more (3 items)

Medtronic

Why: Software problem has the potential for an inaccurate displayed longevity estimate.

Class II: could cause temporary or reversible harm

Nalu Td2 Therapy Disc with Firmware

Boston Scientific Neuromodulation, sold nationwide

Why: Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue that causes the TD to attempt to restart, then fail, leading...

Class II: could cause temporary or reversible harm

Emag System Model/Catalog Number:

Biomerieux Sa, sold nationwide

Why: Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater timeout after updating to recent firmware SP4 Patch 2

Class II: could cause temporary or reversible harm

Model Number:

Philips North America, sold nationwide

Why: Potential for the device to fail immediately after an exposure, causing the system to remain stationary.

Class II: could cause temporary or reversible harm

Precision Pointer Electromagnetic

Stryker Leibinger Gmbh & Co. Kg, sold nationwide

Why: Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the device is inside the patient.

Class II: could cause temporary or reversible harm

Carevo

Arjohuntleigh Polska Sp. Z.O.O., sold nationwide

Why: The side support of the shower trolley may open unintentionally when the handles are not fully locked and additional force is applied during patient handling. If the side support is not fully locked and an additional...

Class II: could cause temporary or reversible harm

Orthoscan Versa Accessory Cart

Ziehm-Orthoscan, sold nationwide

Why: The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the cart.

Class II: could cause temporary or reversible harm

Ethilon Nylon Suture

Ethicon

Why: Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including...

Class II: could cause temporary or reversible harm

Apheresis Platelets

American National Red Cross (the), Lewis and Clark Region

Why: Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced, which were exposed to unacceptable storage temperatures, were distributed.

Class II: could cause temporary or reversible harm

Apheresis Platelets

the American National Red Cross

Why: Apheresis Platelets, PAS, Leukocytes Reduced, which were not tested for pH or platelet count, were distributed.

Class II: could cause temporary or reversible harm

Intelerad Intelepacs Software

Intelerad Medical Systems Incorporated

Why: A cybersecurity vulnerability has been identified in the software that could allow a malicious user to take over an administrator session, delete or modify image or study data, or lock legitimate users out of the...

Class II: could cause temporary or reversible harm

Senographe Pristina (3 items)

Ge Medical Systems

Why: GE HealthCare has become aware of a nonconformance to certain Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisition configuration of the anode track/filter combination is...

Class II: could cause temporary or reversible harm

Cyanocobalamin Injection

American Health Packaging

Why: Presence of particulate matter:American Regent, Inc. notified BluePoint Pharmaceuticals Laboratories regarding potential glass particle contamination (foreign glass fragment) identified in the product batch.

Class II: could cause temporary or reversible harm

About 1.8 million people in the US are prescribed cyanocobalamin each year.

Famotidine Injection

Sagent Pharmaceuticals

Why: Presence of Particulate Matter

Not Yet Classified

About 5.3 million people in the US are prescribed famotidine each year.

Ciprofloxacin Tablets (2 products)

Hikma Pharmaceuticals USA

Why: CGMP Deviations: N-nitroso-ciprofloxacin results above the FDA recommended interim control limit.

Class II: could cause temporary or reversible harm

About 2.5 million people in the US are prescribed ciprofloxacin each year.

Generic Name: Perma Sharp Sutures (13 items)

Henry Schein

Why: Products lack 510(k) clearance.

Class II: could cause temporary or reversible harm

Trusystem and Operating Table Column Ts7500 Mobius and 1 more (5 items)

Baxter Healthcare

Why: There is an issue with the main lift mechanism. The main lift may unexpectedly drop from its set position to its lowest position during use. In these cases, the tabletop could not be raised again after the drop...

Class II: could cause temporary or reversible harm

Starfish Seafood Cold Smoked Trio Salmon Halibut Trout and Starfish Seafood Cold Smoked Norwegian Salmon (2 items)

Krasnyi Oktyabr

Why: Contaminated with Listeria monocytogenes

Class I: could cause serious harm or death

Gelatelli Naturally Flavored Coffee & Vanilla Gelato with Coffee Sauce & Cookie

Lidl US Trading

Why: Listeria monocytogenes. The firm received positive test result of Listeria monocytogenes in the product.

Class I: could cause serious harm or death

Apheresis Platelets

American Red Cross Biomedical Services Northern New England Region

Why: Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced, lacking documentation of return to acceptable storage temperature, were distributed.

Class II: could cause temporary or reversible harm

Apheresis Platelets

American National Red Cross

Why: Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced, which were not tested for residual white blood cells or red blood cells (RBC) after an RBC spillover during apheresis collection, were distributed.

Class II: could cause temporary or reversible harm

Apheresis Platelets

Impactlife

Why: Apheresis Platelets, Leukocytes Reduced, lacking documentation of acceptable storage temperature and agitation, were distributed.

Class II: could cause temporary or reversible harm

Apheresis Platelets

New York Blood Center Enterprises

Why: Apheresis Platelets, Leukocytes Reduced, Irradiated, which tested repeatedly reactive for anti-HCV, were distributed.

Class II: could cause temporary or reversible harm

Unity Knee Asc Modular Handle Included in the Corin Unity Asc Instrument System.

Corin Medical

Why: Potential malfunction of the Modular Handles where the locking mechanism may fail. Any mating instruments already engaged to the handle will not be able to be disengaged, and the handle will be unable to fitted securely...

Class II: could cause temporary or reversible harm

Halyard Minor Pack. Model/Catalog Number: Vasf105-08.

Avid Medical

Why: Potential for open seals on header bags, compromising sterility.

Class II: could cause temporary or reversible harm

Trusystem and Mobile Column Trusystem (2 items)

Baxter Healthcare

Why: The main lift may unexpectedly drop from its set position to its lowest position during use. The tabletop may not be able to be raised again after the drop occurs. An uncontrolled drop of the surgical table may result...

Class II: could cause temporary or reversible harm

Trinias Opera Smart

Shimadzu Corporation Medical Systems Division

Why: The mounting bolts securing the C-arm drive unit of the X-ray system may not be torqued to specification, potentially compromising structural stability and safe operation.

Class II: could cause temporary or reversible harm

Veritas Reverse Total Shoulder Replacement

Restor3d

Why: (Retroactively reported) Pairing of shoulder implant stem sizes 1 and 2 with the largest glenosphere diameter (40 mm) creates an excessive mechanical loading configuration in which certain polyethylene components lack...

Class II: could cause temporary or reversible harm

Cochlear Nucleus Nexa Cochlear Implant with Contour Advance Electrode Ref P19795

Cochlear Limited

Why: Due to a manufacturing deviation of incomplete electrode welds of cochlear implants and resulting in one or more open circuits

Class II: could cause temporary or reversible harm

Yeastone Broth

Remel

Why: Affected lot did not meet specifications. Product may report false susceptibility to antifungal agents, specifically within the Azole family.

Class II: could cause temporary or reversible harm

Cardinal Health Presource Pbds Kits (11 items)

Cardinal Health 200

Why: Kits contain infusion sets which were recalled for performance issues.

Class I: could cause serious harm or death

Generic Name: Edwards Commander M Delivery System Generic Name: Edwards Commande

Edwards Lifesciences

Why: Due to a manufacturing issue which may result in cardiovascular balloon rupturing.

Class I: could cause serious harm or death

Delflex Peritoneal Dialysis Solution with (5 products)

Fresenius Medical Care Renal Therapies Group

Why: Lack of Assurance of Sterility:complaints have been received related to potential leaks from small perforations in the print area on the primary bag in the affected lots.

Class II: could cause temporary or reversible harm

Red Blood Cells

Versiti Michigan

Why: Red Blood Cells, Leukocytes Reduced, quarantined due to Whole Blood collection using a scale that did not undergo daily quality control, were distributed prior to completion of the investigation.

Class II: could cause temporary or reversible harm

Tychasis Coats Aloe Lotion and Tychasis Coats Aloe Creme and 1 more (3 products)

Biomed Laboratories

Why: Failed Stability Specifications: OOS stability results included viscosity and appearance results that did not align with the established specifications.

Class II: could cause temporary or reversible harm

Glutathione

Premium Health Care

Why: Microbial Contamination of Sterile Products: Out of specifications results were obtained for bacterial endotoxin.

Not Yet Classified

Alpha Lipoic Acid and Ascorbic Acid and 29 more (42 products)

Victory Medical Center Pharmacy

Victory Medical Center Pharmacy recalled alpha lipoic acid 25MG/ML 30ML, ascorbic acid 500MG/ML 50ML, preservative-free ascorbic acid 500MG/ML 50ML and B complex 30ML for lack of processing controls. Lots 2051563, 2022189 and other lots expire 10/19/2026 to 12/1/2026.

FDA reason: Lack of Processing Controls

Class II: could cause temporary or reversible harm

About 300,000 people in the US are prescribed ascorbic acid each year.

Tandem Mobi Insulin Pump

Tandem Diabetes Care

Why: Tandem Diabetes Care, Inc. ( Tandem ) has identified that certain Tandem Mobi insulin pumps may generate false-positive occlusion alarms when no actual insulin flow obstruction is present. Investigation determined that...

Class I: could cause serious harm or death

Nextseq and Miseq Dx Instrument Ref: Dx-410-1001 / and 3 more (5 items)

Illumina

Why: (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, servers, or computers) and in vitro diagnostic devices which may...

Class II: could cause temporary or reversible harm

Hemochron Jr.

Accriva Diagnostics

Why: Microcoagulation test used to evaluate low dose heparin anticoagulation has a mispositioned or absent clot activating reagent, which may result in out-of-range high error code, or erroneously high results, which may...

Class II: could cause temporary or reversible harm

Evos

Smith & Nephew

Why: Incorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM Lateral Proximal Tibia Plate 6 hole left 91mm implant

Class II: could cause temporary or reversible harm

Embletta Mpr Pg Multi Parameter Recorder Sleep Monitor

Natus Medical Incorporated

Why: The device may be unable to correctly format its internal memory. When the internal memory cannot be correctly formatted, previously recorded studies may remain on the device and may be updated with incorrect patient...

Class II: could cause temporary or reversible harm

Cryopatch Synergraft

Artivion

Why: A cryopreserved pulmonary human cardiac patch, taken from a 64-year-old human donor, was outside the cardiac tissue donor age specification of newborn to 60 years. The patch was implanted, and due to limitations of...

Class II: could cause temporary or reversible harm

Fludrocortisone Acetate Tablets

Avkare

Why: Failed Impurities/Degradation Specifications

Class II: could cause temporary or reversible harm

Artificial Tears Lubricant Eye Drops

Preferred Pharmaceuticals

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

Pollens - Grasses

Greer Laboratories

Why: Greer Laboratories is requesting a recall for a reported phenol concentration that was recorded at a higher level than the specification limit for lot # 446661 of Standardized Sweet Vernal Grass 100,000 BAU/mL, 5mL...

Class III: unlikely to cause harm

Sterile Diluent for Allergenic Extracts Normal Saline

Greer Laboratories

Why: Greer Laboratories is initiating a voluntary recall of Sterile Diluent for Allergenic Extracts Normal Saline because retention samples from this lot exhibited evidence of glass delamination.

Class III: unlikely to cause harm

Amlodipine and Olmesartan Medoxomil

Ascend Laboratories, sold nationwide

Ascend recalled amlodipine/olmesartan 10mg/40mg, 30-tablet bottles because they did not dissolve as required, so the body may absorb less drug than intended. Lot # 25120696, expiring December 31, 2026, was sold nationwide in the United States.

FDA reason: Out of specification due to dissolution.

Class II: could cause temporary or reversible harm

About 18.4 million people in the US are prescribed amlodipine each year.

Brush Buddies and Evo and 3 more (17 products)

Pritam International Private Limited, sold nationwide

Brush Buddies and evo toothpastes, sodium fluoride 0.24% or 0.243%, 3.5- or 4.0-oz tubes, were recalled because they were not made under federal quality rules. Lots LWP240022080309, LWP250035710304C and other lots, exp. 11/30/2026 to 06/04/2028, were sold nationwide.

FDA reason: CGMP Deviations.

Class II: could cause temporary or reversible harm

About 600,000 people in the US are prescribed sodium fluoride each year.

Levothyroxine Sodium (2 products)

Pfizer, sold nationwide

Levoxyl 175 mcg tablets in 100- and 1000-count bottles were recalled after testing found less active ingredient than the label states. Lots 24W06 and 24W07, expiring 11/30/2026, were sold nationwide and in Puerto Rico.

FDA reason: Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.

Class II: could cause temporary or reversible harm

About 19 million people in the US are prescribed levothyroxine each year.

Telmisartan and Amlodipine

Viatris, sold nationwide

Why: Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications

Class III: unlikely to cause harm

In the news: 13 news outlets mentioned amlodipine in recall stories in the last two weeks.

About 18.4 million people in the US are prescribed amlodipine each year.

Ascorbic Acid

Greenwich Rx, sold nationwide

Why: Microbial Contamination of Sterile Products

Class I: could cause serious harm or death

About 300,000 people in the US are prescribed ascorbic acid each year.

Vocsn and V+ Pro Emergency and 9 more (12 items)

Ventec Life Systems, sold nationwide

Why: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.

Class I: could cause serious harm or death

Argatroban (2 products)

Par Health USA, sold nationwide

Why: Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.

Class I: could cause serious harm or death

Testosterone Cypionate

Right Value Drug Stores, sold nationwide

Why: Lack of sterility assurance.

Class II: could cause temporary or reversible harm

About 1.7 million people in the US are prescribed testosterone each year.

Philips Lumify Diagnostic Ultrasound System

Philips Ultrasound, sold nationwide

Why: Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital...

Class I: could cause serious harm or death

Medline Medical Convenience Kits Labeled As: and Medline Medical Convenience Kits Labeled As and 7 more (13 items)

Medline Industries, sold nationwide

Why: Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Class II: could cause temporary or reversible harm

Heparin Sodium

Shenzhen Techdow Pharmaceutical Co., sold nationwide

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

Direxion Torqueable Microcatheter (41 items)

Boston Scientific Cork, sold nationwide

Why: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser...

Class II: could cause temporary or reversible harm

Lh Lithium Heparin Separator

Greiner Bio-One North America, sold nationwide

Why: Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the...

Class II: could cause temporary or reversible harm

Interstim Percutaneous Extensions Ext and Interstim Surescan Mri Leads (2 items)

Medtronic Neuromodulation, sold nationwide

Why: Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement...

Class II: could cause temporary or reversible harm

B Braun Safsite Injection Site

B Braun Medical, sold nationwide

Why: Potential for leakage and backflow at the Safsite valve.

Class II: could cause temporary or reversible harm

Generic Name: Softmed Breathables Advanced Toric

Coopervision, sold nationwide

Why: The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement...

Class II: could cause temporary or reversible harm

Cinacalcet

Strides Pharma, sold nationwide

Why: Failed dissolution specifications

Class II: could cause temporary or reversible harm

Medtronic Biopsy Needle Kit and Medtronic Ndi Passive Spheres Ref: (4 items)

Medtronic Navigation

Why: Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.

Class II: could cause temporary or reversible harm

Pne Lead Implant Kit Ref:

Axonics, sold nationwide

Why: Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.

Class II: could cause temporary or reversible harm

Abiraterone Acetate

Hikma Pharmaceuticals USA, sold nationwide

Why: Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.

Class II: could cause temporary or reversible harm

Ion Torrent Genexus Dx with Software

Life Technologies Holdings Pte, sold nationwide

Why: DNA or RNA sequencing system software has vulnerabilities.

Class II: could cause temporary or reversible harm

Generic Name: Minimed Go App Generic Name: Minimed Go App Model/Catalog Number

Medtronic Minimed, sold nationwide

Why: A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating...

Class II: could cause temporary or reversible harm

Techno-Path Multichem Ae Unassayed Level and Techno-Path Multichem Ae Unassayed Level (3 items)

Techno-Path Manufacturing, sold nationwide

Why: A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life...

Class II: could cause temporary or reversible harm

Rotor Assy-Sw40 and Rotor Assy-Sw41 (2 items)

Beckman Coulter, sold nationwide

Why: Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run, resulting in destruction of samples being...

Class II: could cause temporary or reversible harm

Carelink Clinic

Medtronic Minimed, sold nationwide

Why: CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily...

Class II: could cause temporary or reversible harm

Think Surgical Square Driver Ref:

Think Surgical, sold nationwide

Why: Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.

Class II: could cause temporary or reversible harm

Philips Smart-Hopping

Philips North America, sold nationwide

Why: Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity to the central monitoring system (PIC...

Class II: could cause temporary or reversible harm

Halyard Anterior Hip Pack. Model/Catalog Number: Soah30. and Halyard Anterior Hip Pack. Model/Catalog Number: Soah31. (2 items)

Avid Medical, sold nationwide

Why: A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.

Class II: could cause temporary or reversible harm

Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers

Abbott, sold nationwide

Why: Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).

Class II: could cause temporary or reversible harm

Generic Name: Restor3d Mtp Implant Generic Name: Mtp Implant Model/Catalog Num

Restor3d, sold nationwide

Why: Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.

Class II: could cause temporary or reversible harm

Xact Mole Marker for Mammography Model/Catalog Number: M15rm

Solstice, sold nationwide

Why: The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.

Class II: could cause temporary or reversible harm

Sterile Diluent for Allergenic Extract

Greer Laboratories

Why: Greer Laboratories dba Stallergenes Greer is recalling distributed Sterile Diluent for Allergenic Extracts Normal Saline due to an out of specification (OOS) phenol level (lower than expected) identified during routine...

Class III: unlikely to cause harm

Cyanocobalamin Injection

American Regent

Why: Presence of Particulate matter: Identified as glass

Class II: could cause temporary or reversible harm

About 1.8 million people in the US are prescribed cyanocobalamin each year.

Red Blood Cells

the American National Red Cross

Why: Red Blood Cells, Leukocytes Reduced, collected from a donor who was deferred for accidental blood exposure, were distributed.

Class II: could cause temporary or reversible harm

Pooled Platelets

We Are Blood

Why: Pooled Platelets, Leukocytes Reduced, Irradiated, which were not tested for pH, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

American Red Cross Blood Svcs

Why: Red Blood Cells, Leukocytes Reduced, prepared from whole blood which may have exceeded the acceptable collection volume, were distributed.

Class III: unlikely to cause harm

Eden Brothers Broccoli Seeds - Calabrese. Sold in Packets

Eden Brothers

Why: Salmonella

Class I: could cause serious harm or death

Zestigreens Broccoli Seeds for Sprouting & Microgreens

Fortuna Marketing

Why: Broccoli seeds potentially contaminated with Salmonella

Class I: could cause serious harm or death

Miyoko'S Creamery European Style Salted Plant Milk Butter

Prosperity Organic Foods

Why: Product recalled due to yeast, mold, and E. coli.

Class II: could cause temporary or reversible harm

Amitriptyline Hydrochloride

Avkare

Why: Failed dissolution specifications.

Class II: could cause temporary or reversible harm

About 1.8 million people in the US are prescribed amitriptyline each year.

Heirloom Homegrown Green Sprouting Calabrese Broccoli Sprouts Seed. Net Wt.

Eak Distribution

Why: Salmonella.

Class I: could cause serious harm or death

Gardners Basics Brand Waltham

Gardeners Basics

Why: Salmonella

Class I: could cause serious harm or death

Ortho Connect

Biomedical Data Solutions Limited

Why: Biomedical Data Solutions is recalling distributed units of the ORTHO CONNECT software due to the software incorrectly rejecting potential discrepant results during the result review process and subsequently exporting...

Class II: could cause temporary or reversible harm

Apheresis Platelets

Arup Laboratories

Why: Apheresis Platelets, PAS, Leukocytes Reduced, which were labeled as leukocytes reduced but were not tested to verify residual white blood cell count and for which pH testing was not performed, were distributed.

Class II: could cause temporary or reversible harm

Sermorelin and Tirzepatide/Niacinamide (2 products)

Houston Rx, sold nationwide

Why: Lack of process control

Class II: could cause temporary or reversible harm

About 3.5 million people in the US are prescribed tirzepatide each year.

Metoclopramide

Teva Pharmaceuticals USA, sold nationwide

Why: Presence of Foreign Tablets/Capsules

Class II: could cause temporary or reversible harm

About 590,000 people in the US are prescribed metoclopramide each year.

Hydrocortisone Sodium Succinate

Zydus Pharmaceuticals (USA), sold nationwide

Why: Failed Impurities/Degradation Specifications.

Class II: could cause temporary or reversible harm

About 1.3 million people in the US are prescribed hydrocortisone each year.

Metoclopramide

American Health Packaging, sold nationwide

Why: Presence of Foreign Tablets/Capsules

Class II: could cause temporary or reversible harm

About 590,000 people in the US are prescribed metoclopramide each year.

Medline Surgical Convenience Kits Labeled As: and Medline Surgical Convenience Kits Labeled As: Open Heart and 3 more (12 items)

Medline Industries, sold nationwide

Why: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Class II: could cause temporary or reversible harm

Hemosll Acustar Hit-Lgg (2 items)

Instrumentation Laboratory, sold nationwide

Why: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.

Class I: could cause serious harm or death

Convenience Kits Containing Conmed Airseal Access Ports Advance Laparoscopic and Convenience Kits Containing Conmed Airseal Access Ports Chn Gyn Oncology D and 3 more (6 items)

Medline Industries, sold nationwide

Why: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.

Class II: could cause temporary or reversible harm

Rapicide Pa Part A High-Level Disinfectant (3 items)

Steris, sold nationwide

Why: If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted...

Class II: could cause temporary or reversible harm

Bd Phoenix Panel Nmic-312. Catalog Number: and Bd Phoenix Panel Nmic-306. Catalog Number: (2 items)

Becton Dickinson &, sold nationwide

Why: Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.

Class II: could cause temporary or reversible harm

Vinyl Instrument Guards

Healthmark Industries Co., sold nationwide

Why: Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.

Class II: could cause temporary or reversible harm

Power F2 Powered Fastening System

Ferno-Washington, sold nationwide

Why: Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibiting reduced powered...

Class II: could cause temporary or reversible harm

Grafton" Dbm and Grafton Plus" Dbm Contain Demineralized Human Bone Tissue Combi and Grafton" Dbm and Grafton Plus" Dbm Contain Demineralized Human Bone Tissue Comb (2 items)

Medtronic Sofamor Danek USA, sold nationwide

Why: Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed...

Class II: could cause temporary or reversible harm

Medline Convenience Kit Labeled As: Foot Ankle. Medline Kit Sku Dynj65395a

Medline Industries, sold nationwide

Why: Discrepancy in the shelf-life of a component

Class II: could cause temporary or reversible harm

Likorall Overhead Lifts Product Code:

Baxter Healthcare, sold nationwide

Why: Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients...

Class II: could cause temporary or reversible harm

Dxu and Iq200 Sprint (2 items)

Beckman Coulter, sold nationwide

Why: The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual...

Class II: could cause temporary or reversible harm

Generic Name: Biofire¿ Joint Infection and Generic Name: Filmarray¿ Pneumonia Panel Plus Generic Name: Filmarray¿ Pneumonia and 1 more (3 items)

Biofire Diagnostics, sold nationwide

Why: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

Class II: could cause temporary or reversible harm

Intelepacs

Intelerad Medical Systems Incorporated, sold nationwide

Why: Following a Chromium-based web-browser, report and displayed images may not match.

Class II: could cause temporary or reversible harm

the Abl90 Flex and Abl90 Flex Plus Analyzers Are Intended for Use By Trained Tec

Radiometer Medical Aps, sold nationwide

Why: In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2)...

Class II: could cause temporary or reversible harm

Iomax Cortical Module

Cadwell Industries, sold nationwide

Why: Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach...

Class II: could cause temporary or reversible harm

Ifuse Torq Implant System Model/Catalog Number:

Si-Bone, sold nationwide

Why: The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.

Class II: could cause temporary or reversible harm

Ref: P65 St862 Colag Screw

In2bones USA, sold nationwide

Why: Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.

Class II: could cause temporary or reversible harm

Jenavalve Trilogy Delivery Catheter (3 items)

Jenavalve Technology, sold nationwide

Why: Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

Class II: could cause temporary or reversible harm

Mas Omni Immune Pro Liquid Assayed Integrated Immunoassay Control

Microgenics, sold nationwide

Why: Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient...

Class II: could cause temporary or reversible harm

Generic Name: Gore Viabil Short Wire Biliary Endoprosthesis

W L Gore & Associates, sold nationwide

Why: The potential for the devices to be mislabeled with the incorrect length.

Class II: could cause temporary or reversible harm

Perma-Hand Silk Black Braided Sterile Nonabsorbable Surgical Suture

Ethicon, sold nationwide

Why: Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If...

Class II: could cause temporary or reversible harm

Forward Gunshot Wound Kit

Integrated Medcraft, sold nationwide

Why: Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause...

Class II: could cause temporary or reversible harm

Curaplex Capnography Etco2/O2 Oral/Nasal Cannula Multipack

Sarnova Hc, sold nationwide

Why: Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.

Class II: could cause temporary or reversible harm

Naviflex Lw Pusher

Boston Scientific, sold nationwide

Why: Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.

Class II: could cause temporary or reversible harm

Neurostar Advanced Therapy System. Contains the Neurostar Hp Coil Assembly Part

Neuronetics, sold nationwide

Why: Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.

Class II: could cause temporary or reversible harm

Wild West Seeds Broccoli Seeds Green Sprouting Calabrese Lot #4105. Net Wt.

Wild West Seed

Why: Salmonella

Class I: could cause serious harm or death

Ts Universal Baseplate Finishing Tray and Triathlon Hinge Femoral Prep Tray. Catalog Number: and 2 more (4 items)

Howmedica Osteonics

Why: Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual...

Class II: could cause temporary or reversible harm

Williams Cystoscopic Injection Needles

Cook Incorporated

Why: The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this...

Class II: could cause temporary or reversible harm

Scout Md

Merit Medical Systems

Why: The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.

Class II: could cause temporary or reversible harm

Leadcare Ii Blood Lead Test Kit. Model/Catalog Number:

Magellan Diagnostics, sold nationwide

Why: In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an...

Class III: unlikely to cause harm

Quad-Mix and Tirzepatide/Cyanocobalamin and 5 more (16 products)

Carolina Infusion, sold nationwide

Why: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Class II: could cause temporary or reversible harm

About 3.5 million people in the US are prescribed tirzepatide each year.

Tirzepatide Injection and Apothecary Nad+ Injection (2 products)

Apothecary Pharma, sold nationwide

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

About 3.5 million people in the US are prescribed tirzepatide each year.

Glycerin, Hypromellose, Polyethylene Glycol 400 and Dextran 70, Polyethylene Glycol 400, Povidone, Tetrahydrozoline HCL and 5 more (8 products)

K.C. Pharmaceuticals, sold nationwide

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

Lidocaine Ointment USP

Preferred Pharmaceuticals, sold nationwide

Why: Failed Content Uniformity Specifications

Class II: could cause temporary or reversible harm

About 610,000 people in the US are prescribed lidocaine each year.

Ascorbic Acid:

Centric Compounding, sold nationwide

Why: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Not Yet Classified

About 300,000 people in the US are prescribed ascorbic acid each year.

Sediplast

Polymedco, Inc. / Polymedco Cancer Diagnostic Products, sold nationwide

Why: During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting...

Class II: could cause temporary or reversible harm

Tretinoin (3 products)

Sun Pharmaceutical Industries, sold nationwide

Why: Failed Impurities/Degradation Specifications

Class III: unlikely to cause harm

About 1.7 million people in the US are prescribed tretinoin each year.

Verify Biological Steam Test Pack Model/Catalog Number: S3065 and Verify Biological/Integrator Challenge Pack Model/Catalog Number: Lcb006 and 4 more (6 items)

Steris, sold nationwide

Why: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological...

Class II: could cause temporary or reversible harm

Battle Bandage

Safeguard US Operating, sold nationwide

Why: Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection.

Class II: could cause temporary or reversible harm

Robotic Prostatectomy Pack and Adult Heart Tray Shands Jacks and 13 more (15 items)

Avid Medical, sold nationwide

Why: Product may be potentially contaminated with a lubricant used during the manufacturing process.

Class II: could cause temporary or reversible harm

Epm Series Patient Monitor. Patient Monitor Series: Epm and Benevision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22 and 6 more (8 items)

Mindray Ds USA, sold nationwide

Why: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Class III: unlikely to cause harm

Fosfomycin Tromethamine

Cipla USA, sold nationwide

Why: Failed Impurities/Degradation Specifications

Class II: could cause temporary or reversible harm

Bard Ep Xt Decapolar Steerable

Stryker Sustainability Solutions, sold nationwide

Why: Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma...

Class II: could cause temporary or reversible harm

Minimed Flex Insulin Pump

Medtronic Minimed, sold nationwide

Why: Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The...

Class II: could cause temporary or reversible harm

Spectral Ct and Spectral Ct

Philips Medical Systems, sold nationwide

Why: Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.

Class II: could cause temporary or reversible harm

Rollator (2 items)

Medline Industries, sold nationwide

Why: The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach...

Class II: could cause temporary or reversible harm

Onkos Surgical Inc. My3d Personalized Pelvic Implant (2 items)

Onkos Surgical, sold nationwide

Why: Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

Class II: could cause temporary or reversible harm

Nihon Kohden Cns-6200 Series Central Nurse Station

Nihon Kohden America, sold nationwide

Why: Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.

Class II: could cause temporary or reversible harm

Glypto Device

Limitless Cryo Spa, sold nationwide

Why: Lack of 510(k) clearance.

Class II: could cause temporary or reversible harm

Hexavue Focus Integration System

Steris, sold nationwide

Why: A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect...

Class II: could cause temporary or reversible harm

Dxc (2 items)

Beckman Coulter, sold nationwide

Why: Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system...

Class II: could cause temporary or reversible harm

Halyard Laparoscopy Comprehensive Pack Ii Ref:

Gri Medical & Electronic Technology Co., sold nationwide

Why: Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter

Class II: could cause temporary or reversible harm

Alphenix Infx-8000c/B5

Canon Medical System, USA, sold nationwide

Why: Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error

Class II: could cause temporary or reversible harm

Beach Chair Surgical Patient Positioner

Quantum Ops, sold nationwide

Why: Due to a manufacturing issue (inadequate weld) for patient head positioning system.

Class II: could cause temporary or reversible harm

Intellijoint Navigation System: Workstation G2 Configured

Intellijoint Surgical, sold nationwide

Why: A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may...

Class II: could cause temporary or reversible harm

Sperm Ab Elisa

Drg International, sold nationwide

Why: Potential for false negative patient results.

Class II: could cause temporary or reversible harm

Tuftex¿ Over-the-Wire Embolectomy Catheter

Lemaitre Vascular, sold nationwide

Why: Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.

Class II: could cause temporary or reversible harm

Nipocalimab-Aahu

J&J Innovative Medicine

Why: Presence of particulate matter.

Class II: could cause temporary or reversible harm

Biospectra Tris/Tromethamine

Biospectra

Why: Failed stability specifications

Class II: could cause temporary or reversible harm

Presource Packs Containing Medtronic Microstream Components: Intubation Kit

Cardinal Health 200

Why: Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a...

Class II: could cause temporary or reversible harm

Generic Name: Kit

Medical Action Industries, Inc. 306

Why: An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.

Class III: unlikely to cause harm

Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories Mdr1070 and Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories (2 items)

Medline Industries, sold nationwide

Why: Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire....

Class I: could cause serious harm or death

Ventstar Resus Neo. Neonatal.

Draeger, sold nationwide

Why: Potential cracks in the hose, which could lead to leakage or the hose falling off.

Class I: could cause serious harm or death

Estradiol Transdermal

Amneal Pharmaceuticals, sold nationwide

Why: Defective Container; packets were found to be either empty or partially full.

Class II: could cause temporary or reversible harm

About 4.1 million people in the US are prescribed estradiol each year.

Paroxetine Hydrochloride

Apotex, sold nationwide

Why: Failed dissolution specifications.

Class II: could cause temporary or reversible harm

About 1.7 million people in the US are prescribed paroxetine each year.

Disposable Tourniquet Cuff and Disposable Bb Tournquet Cuff and 1 more (64 items)

Asp Global, sold nationwide

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Class II: could cause temporary or reversible harm

Intrapulmonary Percussive Ventilation and in-Line Valve and 2 more (7 items)

Percussionaire, sold nationwide

Why: Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting...

Class II: could cause temporary or reversible harm

Benzoyl Peroxide Wash (2 products)

Sv Labs Toronto

Why: Microbial contamination of topical product.

Class II: could cause temporary or reversible harm

About 180,000 people in the US are prescribed benzoyl peroxide each year.

Buprenorphine Hydrochloride

Par Health USA, sold nationwide

Why: Crystallization

Class II: could cause temporary or reversible harm

Performance Pro and Opportunity Flex and 1 more (3 items)

American Nitrile Operations, sold nationwide

Why: Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination...

Class II: could cause temporary or reversible harm

Fisher Scientific Sure-Vue Serum/Urine Hcg and Fisher Scientific Sure-Vue Urine Hcg and 2 more (4 items)

Alere San Diego, sold nationwide

Why: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Class II: could cause temporary or reversible harm

Palacos Mv+G Pro and Palacos Mv Pro and 2 more (4 items)

Heraeus Medical Gmbh (Dental Division), sold nationwide

Why: Potential for monomer liquid leakage.

Class II: could cause temporary or reversible harm

Ingenia and Mr and 8 more (12 items)

Philips North America, sold nationwide

Why: When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction...

Class II: could cause temporary or reversible harm

Quantum Pureflow Standard Heat Exchanger High Flow (2 items)

Spectrum Medical Srl, sold nationwide

Why: Due to blood-to-glycol leak in the heat exchanger.

Class II: could cause temporary or reversible harm

Computed Tomography X-Ray System and Positron Emission Tomography and Computed Tomography System (12 items)

Shanghai United Imaging Healthcare Co., sold nationwide

Why: Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images...

Class II: could cause temporary or reversible harm

Atellica Ch Revised C-Reactive Protein

Siemens Healthcare Diagnostics, sold nationwide

Why: The potential for falsely elevated results.

Class II: could cause temporary or reversible harm

Hypromellose Eye Drops 0.7%

Aurolab Trust

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

Goserelin

Tersera Therapeutics, sold nationwide

Why: Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.

Class II: could cause temporary or reversible harm

Ranolazine

Ajanta Pharma USA, sold nationwide

Why: Failed Dissolution Specifications: below specification

Class II: could cause temporary or reversible harm

Embosphere

Merit Medical Systems, sold nationwide

Why: Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.

Class II: could cause temporary or reversible harm

Presource Packs Containing Stryker Strykeflow Ps and Ahto Tube Sets: (4 items)

Cardinal Health 200, sold nationwide

Why: The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user...

Class II: could cause temporary or reversible harm

Medical Convenience Kits Containing Bd Cliniclean Pericare Wipes Within Bd Urina (3 items)

American Contract Systems, sold nationwide

Why: Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to...

Class II: could cause temporary or reversible harm

Philips Intrasight Plus Ref:

Volcano, sold nationwide

Why: Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.

Class II: could cause temporary or reversible harm

Mastisol Skin Adhesive

Custom Interventional Pain Management, sold nationwide

Why: Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.

Class II: could cause temporary or reversible harm

Penumbra System

Penumbra, sold nationwide

Why: Due to manufacturing issues reperfusion catheters may fracture.

Class II: could cause temporary or reversible harm

Novaseq

Illumina, sold nationwide

Why: Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server with a security vulnerability.

Class II: could cause temporary or reversible harm

Pipeline Flex Embolization Device with Shield Technology Ref Ped2-300-12 Udi-Di

Micro Therapeutics, sold nationwide

Why: Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.

Class II: could cause temporary or reversible harm

Encor Encompass Breast Biopsy and Tissue Removal System Console

Bard Peripheral Vascular, sold nationwide

Why: Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to...

Class II: could cause temporary or reversible harm

Charlotte Claw Screw

Wright Medical Technology, sold nationwide

Why: Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the...

Class II: could cause temporary or reversible harm

Olympus Tripp-Lite P580-025

Olympus Corporation of the Americas, sold nationwide

Why: While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.

Class II: could cause temporary or reversible harm

Systems/Units Containing Affected Software/Sql Beckman Coulter Chemistry Analyz

Beckman Coulter Mishima K.K., sold nationwide

Why: Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC...

Class II: could cause temporary or reversible harm

Tandem T:Slim Mobile Application Product Name: T:Slim Mobile Application

Tandem Diabetes Care, sold nationwide

Why: A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose...

Class II: could cause temporary or reversible harm

Noxboxi Nitric Oxide Delivery System. Model Number: Noxbox-I.

Noxbox, sold nationwide

Why: Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.

Class II: could cause temporary or reversible harm

Hopkins Telescope

Karl Storz Endoscopy, sold nationwide

Why: Due to incorrect inside packaging label for eyepiece.

Class II: could cause temporary or reversible harm

Philips Medical Systems Technologies Ltd. Spectral Ct

Philips North America

Why: The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional...

Class II: could cause temporary or reversible harm

Olympus M3 Gold Autoclavable Foroblique Telescope and Olympus M3 Gold Autoclavable Lateral Telescope (2 items)

Olympus Corporation of the Americas

Why: There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

Class II: could cause temporary or reversible harm

Heartsine Samaritan Pad

Heartsine Technologies, sold nationwide

Why: Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.

Class III: unlikely to cause harm

Imager Ii Angiographic Catheters M001314001 Imager Ii/5/St/65/038 Bx5

Boston Scientific, sold nationwide

Why: Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.

Class I: could cause serious harm or death

Inca (2 items)

Coopersurgical, sold nationwide

Why: Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and...

Class I: could cause serious harm or death

Carboxymethylcellulose Sodium and Lubricant Eye Drops-Cameron Pharmaceuticals and 3 more (9 products)

Sterling Pharmaceutical Services, sold nationwide

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

Halyard IV Start Kit Non-Sterile

Avid Medical, sold nationwide

Why: Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.

Class I: could cause serious harm or death

Clear Eyes Redness Relief (2 products)

Insight Pharmaceuticals LLC, A Prestige Consumer Healthcare, sold nationwide

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

Olanzapine

Macleods Pharmaceuticals Limited, sold nationwide

Why: Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.

Class III: unlikely to cause harm

About 670,000 people in the US are prescribed olanzapine each year.

Combiset Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer

Fresenius Medical Care Renal Therapies Group, sold nationwide

Why: Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

Class II: could cause temporary or reversible harm

Achieva and Ingenia Elition S and Ingenia Elition X and 7 more (12 items)

Philips North America, sold nationwide

Why: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Class II: could cause temporary or reversible harm

Cardioroot Woven Collagen Coated Vascular Graft

Intervascular, Sas, sold nationwide

Why: Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).

Class II: could cause temporary or reversible harm

Medline Convenience Kits: (5 items)

Medline Industries, sold nationwide

Why: The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as...

Class II: could cause temporary or reversible harm

Presource Convenience Kits: (2 items)

Cardinal Health 200, sold nationwide

Why: The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or...

Class II: could cause temporary or reversible harm

Foresight Elite Tissue Oximetry Cable Ref Hemfsm10 Udi-Di Code:

Becton, Dickinson and, sold nationwide

Why: Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.

Class II: could cause temporary or reversible harm

Exenatide

Amneal Pharmaceuticals of New York, sold nationwide

Why: Defective Delivery System: Possibility of no medication in the prefilled pen.

Class II: could cause temporary or reversible harm

Olympus Bicoag Hemostasis Probe (4 items)

Olympus Corporation of the Americas, sold nationwide

Why: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Class II: could cause temporary or reversible harm

Medline Convenience Kits Containing Healthmark Instrument Channel Brushes. Sinus and Medline Convenience Kits Containing Healthmark Instrument Channel Brushes. Sin (2 items)

Medline Industries, sold nationwide

Why: Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion...

Class II: could cause temporary or reversible harm

Midmark Iqvitals Zone (4 items)

Midmark, sold nationwide

Why: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Class II: could cause temporary or reversible harm

Automated Impella Controller

Abiomed, sold nationwide

Why: Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system...

Class II: could cause temporary or reversible harm

Ngenuity Patient Monitor with Capnography

Criticare Technologies, sold nationwide

Why: Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.

Class II: could cause temporary or reversible harm

Vitek

Biomerieux

Why: The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False...

Class II: could cause temporary or reversible harm

Spectralis with Flex Module

Heidelberg Engineering Gmbh, sold nationwide

Why: Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries...

Class II: could cause temporary or reversible harm

Ref: Hf2postd Homefill Oxygen System Homefill Cylinder D with Cga870 Compatibl and Ref:Hf2pc9 Homefill Oxygen System and 1 more (3 items)

Ventec Life Systems, sold nationwide

Why: Labeling; Oxygen Cylinders do not contain required medical gas labeling

Class II: could cause temporary or reversible harm

New York Embroidery Studio Trinity Non-Surgical Isolation Gown

New York Embroidery Studio, sold nationwide

Why: Gowns do not consistently meet the minimum liquid-barrier performance required.

Class II: could cause temporary or reversible harm

Ref:

Deroyal Industries, sold nationwide

Why: Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.

Class II: could cause temporary or reversible harm

Pro+ and Pro+ Mrs Surface for Versacare (3 items)

Baxter Healthcare, sold nationwide

Why: There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect...

Class II: could cause temporary or reversible harm

Halyard IV Start Kit Non-Sterile (2 items)

Avid Medical, sold nationwide

Why: Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.

Class II: could cause temporary or reversible harm

Contact Lens

Coopervision, sold nationwide

Why: A small number of lenses within the affected lot are of the incorrect power.

Class II: could cause temporary or reversible harm

Powerled

Maquet Sas, sold nationwide

Why: The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.

Class II: could cause temporary or reversible harm

Philips Epiq Elite Diagnostic Ultrasound System Model #

Philips Ultrasound, sold nationwide

Why: Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.

Class II: could cause temporary or reversible harm

Extended Polyaxial Head

Seaspine Orthopedics, sold nationwide

Why: The proximal thread depth of the spinal device is out of design specification.

Class II: could cause temporary or reversible harm

Volara

Baxter Healthcare, sold nationwide

Why: Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.

Class II: could cause temporary or reversible harm

Menow Sunscreen Pressed Powder Spf35 Pa+++

Shantou Qiwei Industrial Co.

Why: cGMP Deviations

Class II: could cause temporary or reversible harm

Olympus Ezdilate Endoscopic Balloon Dilator Wired-Guided

Olympus Corporation of the Americas

Why: Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,

Class II: could cause temporary or reversible harm

Thyroid

Vitruvias Therapeutics, sold nationwide

Why: Superpotent Drug

Class I: could cause serious harm or death

About 1.2 million people in the US are prescribed thyroid each year.

Chlorthalidone

Inventia Healthcare Limited, sold nationwide

Why: Failed Dissolution Specifications

Class II: could cause temporary or reversible harm

About 1.3 million people in the US are prescribed chlorthalidone each year.

Medline Convenience Kits: (7 items)

Medline Industries, sold nationwide

Why: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin...

Class I: could cause serious harm or death

Statstrip Glucose and B- Ketone Meter. Model No: and Statstrip Glucose Hospital Meter System. Model No: (5 items)

Nova Biomedical, sold nationwide

Why: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID)...

Class I: could cause serious harm or death

Lidocaine

Sun Pharma /Taro, sold nationwide

Why: Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

Class II: could cause temporary or reversible harm

About 610,000 people in the US are prescribed lidocaine each year.

Automated Impella Controller and Impella Optical Controller with the Below Product Descriptions and Corresponding and 1 more (3 items)

Abiomed, sold nationwide

Why: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Class I: could cause serious harm or death

Power-Trialysis Short-Term Straight Dialysis Catheter and Duoglide Short-Term Straight Dialysis Catheter (2 items)

Bard Access Systems

Why: this is a downstream recall of class I recall RES 98777

Class I: could cause serious harm or death

Bd Alaris Pump Infusion Sets

Bd Switzerland Sarl

Why: Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.

Class I: could cause serious harm or death

Ref:2b5st Ethicon Endo-Surgery and Ref:B5st Ethicon Endo-Surgery and 4 more (6 items)

Stryker Sustainability Solutions, sold nationwide

Why: Reusable access port system may crack or seperate during use.

Class II: could cause temporary or reversible harm

Oncology Sets with Drip Chambers and IV Sets with Drip Chambers and 2 more (8 items)

Icu Medical, sold nationwide

Why: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not...

Class II: could cause temporary or reversible harm

Scorpio C-Dome Patella 73-2710 73-2910 Scorpio U-Dome Patella 73-311 and Abg I Acetabular Insert Hooded and 10 more (12 items)

Howmedica Osteonics, sold nationwide

Why: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in...

Class II: could cause temporary or reversible harm

Halyard IV Start Kit Non-Sterile Ref: Kriv26-02

Avid Medical, sold nationwide

Why: Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides

Class I: could cause serious harm or death

Haylard and Haylard Univ Imaging Biopsy Trucustom and 2 more (4 items)

Avid Medical

Why: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

Class I: could cause serious harm or death

Hemospray Endoscopic Hemostat

Wilson-Cook Medical, sold nationwide

Why: Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

Class II: could cause temporary or reversible harm

Percutaneous Insertion Kit (3 items)

Maquet Cardiopulmonary Gmbh, sold nationwide

Why: The packaging may not consistently maintain sterile barrier integrity.

Class II: could cause temporary or reversible harm

Cadd Yellow Medication Cassette Reservoir with Nrfit Connector US Product Cod

Icu Medical, sold nationwide

Why: Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or...

Class II: could cause temporary or reversible harm

Fluphenazine HCL Elixir (6 products)

Safecor Health, sold nationwide

Why: Failed Stability Specifications

Class II: could cause temporary or reversible harm

Carescape Central Station Cscs V3 Mas800 Desktop Part Number

Ge Medical Systems Information Technologies, sold nationwide

Why: Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.

Class II: could cause temporary or reversible harm

Happiest Baby (2 items)

Happiest Baby, sold nationwide

Why: Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.

Class II: could cause temporary or reversible harm

Centricity Pacs Server V7 and Centricity Pacs V2 and 4 more (6 items)

Ge Healthcare, sold nationwide

Why: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient...

Class II: could cause temporary or reversible harm

Medrad¿ Stellant Flex Syringe Kit Used with Stellant Flex Ct Injection System

Bayer Medical Care, sold nationwide

Why: Some devices may not have been properly sterilized due to a manufacturing sterilization issue.

Class II: could cause temporary or reversible harm

Sunmed Tracheal Tube

Well Lead Medical Co., sold nationwide

Why: The 6Fr suction catheter could not pass through the samples smoothly.

Class II: could cause temporary or reversible harm

Dopamine Hydrochloride

Pfizer, sold nationwide

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

Aisys Cs2 with Et Control and Et Control and 2 more (4 items)

Datex-Ohmeda, sold nationwide

Why: Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling...

Class II: could cause temporary or reversible harm

Medline Convenience Kit: Open Heart A Pack

Medline Industries, sold nationwide

Why: The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior...

Class II: could cause temporary or reversible harm

Philips Pic Ix Essentials Ref:867093 and Philips Patient Information Center Ix Ref:866389 (2 items)

Philips North America, sold nationwide

Why: Due to software malfunction, patient information system may freeze and become unresponsive.

Class II: could cause temporary or reversible harm

Reign Medical Clench Staple System

F & A Foundation, sold nationwide

Why: Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.

Class II: could cause temporary or reversible harm

Captus

Mirion Technologies (Capintec), sold nationwide

Why: Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.

Class II: could cause temporary or reversible harm

Pi-Cardia Inc. Shortcut Ref: Z-A-20.003-US

Pi Cardia, sold nationwide

Why: Transfemoral catheter, positing arm may detached due to weld issue.

Class II: could cause temporary or reversible harm

Boston Scientific Corporation Stonesmart Connect Console Contents:

Boston Scientific, sold nationwide

Why: A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during...

Class II: could cause temporary or reversible harm

Convenience Kits Myringotomy Pack-Lf Dynj59097a and Convenience Kits Anesthesia Pain Pk League Dynj67925a and 2 more (4 items)

Medline Industries, sold nationwide

Why: Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.

Class II: could cause temporary or reversible harm

Noxboxi Nitric Oxide Delivery System.

Noxbox, sold nationwide

Why: Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.

Class II: could cause temporary or reversible harm

Rt Montecarlo

Ptw Freiburg, sold nationwide

Why: When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment...

Class II: could cause temporary or reversible harm

Ewo_02512 and Ewo_02513 (2 items)

Embecta Medical Ii, sold nationwide

Why: Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.

Class II: could cause temporary or reversible harm

Gm Helix Implant

Straumann USA, sold nationwide

Why: There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

Class II: could cause temporary or reversible harm

Kinos Axiom Total Ankle System with Axiom Psr

Restor3d, sold nationwide

Why: Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants...

Class II: could cause temporary or reversible harm

Dash Rapid Pcr Instrument

Nuclein, sold nationwide

Why: Due to a software issue

Class II: could cause temporary or reversible harm

Blood Culture Collection Venipuncture Kit

Medical Action Industries, Inc. 306, sold nationwide

Why: Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may...

Class II: could cause temporary or reversible harm

Epinephrine

American Regent, sold nationwide

Why: Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.

Class I: could cause serious harm or death

About 1.1 million people in the US are prescribed epinephrine each year.

Sodium Chloride

B Braun Medical, sold nationwide

Why: Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene

Class I: could cause serious harm or death

Bravo Cf Capsule Delivery Device

Given Imaging, sold nationwide

Why: Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding...

Class I: could cause serious harm or death

Dextrose Injection

Baxter Healthcare, sold nationwide

Why: Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.

Class I: could cause serious harm or death

Products That Contain the Pericare Wipes: Surestep" Foley Tray System Add-A-Fol and Products That Contain the Pericare Wipes: Bard¿ Foley Tray with Lubri-Sil¿ All- and 4 more (6 items)

C.R. Bard, sold nationwide

Why: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

Class II: could cause temporary or reversible harm

Kit: Single Shot Epidural and Kit: Epidural/Pain Tqc (2 items)

Medical Action Industries, Inc. 306

Why: Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.

Class I: could cause serious harm or death

Medicalyte Liquid Bicarbonate Concentrate Ref: Bc-100 and Bc+201 and Citric Complete Liquid Citric Acid Concentrate Ref: Lc+200-D and 2 more (4 items)

Nipro Renal Soultions USA, sold nationwide

Why: Hemodialysis concentrates contain high endotoxin levels

Class II: could cause temporary or reversible harm

Heartsine Sam

Heartsine Technologies, sold nationwide

Why: Due to a damaged (over stretched) membrane tail that causes an intermittent fault.

Class II: could cause temporary or reversible harm

Fentanyl Citrate

Ourpharma, sold nationwide

Why: Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).

Class II: could cause temporary or reversible harm

Fluphenazine Hydrochloride

Ajanta Pharma USA, sold nationwide

Why: Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.

Class III: unlikely to cause harm

Dermav Laser System

Lutronic, sold nationwide

Why: Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.

Class II: could cause temporary or reversible harm

Getinge Pvc Thoracic Catheter (3 items)

Atrium Medical, sold nationwide

Why: An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

Class II: could cause temporary or reversible harm

Ams Convenience Kit: Dsaek Pack - Rx

Windstone Medical Packaging, sold nationwide

Why: The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.

Class II: could cause temporary or reversible harm

Halyard IV Start Kit Non-Sterile Ref: Kriv26-02

Avid Medical, sold nationwide

Why: Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.

Class II: could cause temporary or reversible harm

Povidone Iodine

Imprimisrx Nj, sold nationwide

Why: Subpotent Drug

Class III: unlikely to cause harm

Clindamycin Phosphate and Vasopressin and 8 more (17 products)

Baxter Healthcare, sold nationwide

Why: CGMP Deviations

Class II: could cause temporary or reversible harm

About 2.6 million people in the US are prescribed clindamycin each year.

Trazodone Hydrochloride

Teva Pharmaceuticals USA, sold nationwide

Why: Presence of Foreign Tablets/Capsules

Class II: could cause temporary or reversible harm

About 6.4 million people in the US are prescribed trazodone each year.

Ascorbic Acid

Optimal Balance Pharmacy, sold nationwide

Why: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Class I: could cause serious harm or death

About 300,000 people in the US are prescribed ascorbic acid each year.

Chlorhexidine Gluconate

Sage Products, sold nationwide

Why: Cross Contamination with Other Products

Class II: could cause temporary or reversible harm

About 960,000 people in the US are prescribed chlorhexidine each year.

Sodium Chloride

Baxter Healthcare

Why: Presence of particulate matter: Particulates identified as fiberglass

Class I: could cause serious harm or death

Mycophenolate Mofetil

Mylan Pharmaceuticals, sold nationwide

Why: Failed Dissolution Specifications

Class II: could cause temporary or reversible harm

About 160,000 people in the US are prescribed mycophenolate mofetil each year.

Topiramate) Extended-Release Capsules

Supernus Pharmaceuticals, sold nationwide

Why: Failed dissolution specifications.

Class III: unlikely to cause harm

About 2 million people in the US are prescribed topiramate each year.

Medline Convenience Kits: (16 items)

Medline Industries, sold nationwide

Why: The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the...

Class II: could cause temporary or reversible harm

Medline Convenience Kits Containing Bd Chloraprep Clear - (13 items)

Medline Industries, sold nationwide

Why: Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially...

Class II: could cause temporary or reversible harm

Healon Endocoat Pro

Johnson & Johnson Surgical Vision, sold nationwide

Why: Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion...

Class II: could cause temporary or reversible harm

the One Spf (4 products)

Allies Group, sold nationwide

Why: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

Class II: could cause temporary or reversible harm

Prasugrel

Mylan Pharmaceuticals, sold nationwide

Why: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

Class II: could cause temporary or reversible harm

Halyard Medical Convenience Kits Labeled As: and 1) Neuro (3 items)

Avid Medical, sold nationwide

Why: The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected...

Class II: could cause temporary or reversible harm

Presource Packs Containing Cliniclean Pericare Wipes Within Bd Urinary Catheter (12 items)

Cardinal Health 200, sold nationwide

Why: The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin...

Class II: could cause temporary or reversible harm

5008x Hd/Hdf with Twister Blood Tubing Set Part Number and 5008x Standard Hd Pre-Flush Standard Blood Tubing Set Part Number and 2 more (4 items)

Fresenius Medical Care Renal Therapies Group, sold nationwide

Why: Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

Class II: could cause temporary or reversible harm

Granuflo Dry Acid Concentrate: Product Numbers: and Naturalyte and 1 more (3 items)

Fresenius Medical Care Renal Therapies Group, sold nationwide

Why: Complaints of blue-green discoloration in product

Class II: could cause temporary or reversible harm

Baxter Novum Iq Syringe Pump (2 items)

Baxter Healthcare, sold nationwide

Why: A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

Class II: could cause temporary or reversible harm

Discofix Four Way Stopcock

B Braun Medical, sold nationwide

Why: Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.

Class II: could cause temporary or reversible harm

Doxylamine Succinate and Pyridoxine Hydrochloride

Bionpharma, sold nationwide

Why: Presence of Foreign Tablets/Capsules

Class III: unlikely to cause harm

Prasugrel

Golden State Medical Supply, sold nationwide

Why: Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution

Class II: could cause temporary or reversible harm

Sta Staclot Protein S

Diagnostica Stago, sold nationwide

Why: A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified

Class II: could cause temporary or reversible harm

Lux-Dx (3 items)

Boston Scientific, sold nationwide

Why: There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical...

Class II: could cause temporary or reversible harm

Velys Enabling Tech Robotic-Assist Station Ref:

Medos International Sarl, sold nationwide

Why: Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.

Class II: could cause temporary or reversible harm

Buprenorphine

American Health Packaging, sold nationwide

Why: Labeling: Label Mix-up

Class III: unlikely to cause harm

Broadway Joe'S Pain Cream (2 products)

Lexia

Why: CGMP Deviations: Potential contamination of raw material

Class II: could cause temporary or reversible harm

Philips Brilliance Ct and Philips Ingenuity Ct Product Codes: Ingenuity Ct Upgrades and 2 more (4 items)

Philips North America

Why: Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

Class II: could cause temporary or reversible harm

Elapegademase-Lvlr

Chiesi USA

Why: Failed Stability Specifications: Out of specification stability result for the protein concentration profile.

Class III: unlikely to cause harm

Levothyroxine Sodium (12 products)

Accord Healthcare, sold nationwide

Accord recalled 25, 50, 125 and 200 mcg levothyroxine tablets in 1000-count bottles, and 200 mcg in 90-count bottles, after tests found less active ingredient than labeled. Lots D2402430, D2402431 and other lots, expiring 08/31/2026 to 01/31/2027, went nationwide.

FDA reason: Subpotent Drug

Class II: could cause temporary or reversible harm

About 19 million people in the US are prescribed levothyroxine each year.

Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride

B Braun Medical, sold nationwide

Why: Presence of Particulate matter.

Class I: could cause serious harm or death

About 4.1 million people in the US are prescribed potassium chloride each year.

Ramipril

Hikma Pharmaceuticals USA, sold nationwide

Why: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

Class II: could cause temporary or reversible harm

About 440,000 people in the US are prescribed ramipril each year.

Clobetasol Propionate

Lupin Pharmaceuticals, sold nationwide

Why: Failed content uniformity specifications.

Class II: could cause temporary or reversible harm

About 2.2 million people in the US are prescribed clobetasol each year.

Paroxetine

Apotex, sold nationwide

Why: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria

Class II: could cause temporary or reversible harm

About 1.7 million people in the US are prescribed paroxetine each year.

Tocilizumab-Aazg

Fresenius Kabi USA, sold nationwide

Why: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

Class I: could cause serious harm or death

Zicam

Church & Dwight Co., sold nationwide

Why: CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing

Class II: could cause temporary or reversible harm

Medline Breathing Circuits Labeled As: and Medline Hudson Rci (3 items)

Medline Industries, sold nationwide

Why: Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of...

Class II: could cause temporary or reversible harm

Onli

Hollister Ulc, sold nationwide

Why: Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.

Class II: could cause temporary or reversible harm

Acthar Gel

Mallinckrodt Hospital Products, sold nationwide

Why: Presence of particulate matter: glass and stopper piece

Class II: could cause temporary or reversible harm

Medline Convenience Kits Labeled As: and Medline Convenience Kits Labeled As: Ltp Cds-Lf and 1 more (11 items)

Medline Industries, sold nationwide

Why: Kits contain a potentially contaminated component which were recalled by the manufacturer

Class II: could cause temporary or reversible harm

Halyard Total Joint Model/Catalog Number: Msbm036-03 and Davinci Trucustom Bundle Containing Tray Foley (7 items)

Avid Medical, sold nationwide

Why: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Class II: could cause temporary or reversible harm

Ort200 and Ort300 (2 items)

Imris Imaging, sold nationwide

Why: The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the...

Class II: could cause temporary or reversible harm

Powerseal

Olympus Corporation of the Americas, sold nationwide

Why: Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

Class II: could cause temporary or reversible harm

Fresenius Medical Care

Fresenius Medical Care Renal Therapies Group, sold nationwide

Why: Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.

Class II: could cause temporary or reversible harm

Merge Pacs and Merge Orthopacs

Merge Healthcare, sold nationwide

Why: Software issue may cause measurements to be displayed inaccurately.

Class II: could cause temporary or reversible harm

Alphenix Models Infx-8000c Infx-8000f Infx-8000v This Device Is A Digital

Canon Medical System, USA, sold nationwide

Why: Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.

Class II: could cause temporary or reversible harm

Medline Medical Convenience Kits (4 items)

Medline Industries, sold nationwide

Why: Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

Class II: could cause temporary or reversible harm

American Contract System Convenience Kit and American Contract System Convenience Kits (4 items)

American Contract Systems, sold nationwide

Why: The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable...

Class II: could cause temporary or reversible harm

Medline Medical Convenience Kit Labeled As: Trach Tube Kit

Medline Industries, sold nationwide

Why: Component labeling discrepancy

Class II: could cause temporary or reversible harm

Midmark Digital Ecg Hd+12 and Midmark Iqecg Digital Ecg (2 items)

Midmark, sold nationwide

Why: A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

Class II: could cause temporary or reversible harm

Structur and Grandio Universal Nano-Hybrid Restorative Material - Capsules (2 items)

Henry Schein, sold nationwide

Why: Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

Class II: could cause temporary or reversible harm

Conmed Linvatec Genesys Crossft Suture Anchor with Disposable Driver Ref# Cfbc

Conmed, sold nationwide

Why: Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.

Class II: could cause temporary or reversible harm

Healthmark Prochek-Ii and Healthmark Prochek-W Protein Test for Robotic Arms (2 items)

Healthmark Industries Co., sold nationwide

Why: Test manufactured with an expired ingredient which may present as either a false negative or positive.

Class II: could cause temporary or reversible harm

Fujifilm Synapse Pacs Software V7.4.310

Fujifilm Healthcare Americas, sold nationwide

Why: Software issue may cause the ruler measurement to be inaccurate.

Class II: could cause temporary or reversible harm

Philips Incisive Ct with Software V4.5&V5.0

Philips Healthcare (Suzhou) Co., sold nationwide

Why: Potential of failing to trigger clinical scan during Bolus Tracking.

Class II: could cause temporary or reversible harm

Portrait Core Services Software V1.0.5 and Portrait Compute and Core Services V1.2 and 2 more (4 items)

Ge Medical Systems Information Technologies

Why: Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings...

Class II: could cause temporary or reversible harm

Cyanocobalamin and Trace Elements Injection 4 and 7 more (12 products)

American Regent, sold nationwide

Cyanocobalamin 10,000 mcg/10 mL, Multrys (Trace Elements Injection 4), acetylcysteine 20%, and papaverine 60 mg/2 mL vials were recalled because particles were found. Lots 25082, 25163 and other lots, expiring 9/30/2026 to 8/31/2027, were sold nationwide in the U.S.

FDA reason: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Class I: could cause serious harm or death

About 1.8 million people in the US are prescribed cyanocobalamin each year.

Morphine Sulfate

Fresenius Kabi USA, sold nationwide

Why: Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Class I: could cause serious harm or death

About 590,000 people in the US are prescribed morphine each year.

Boston Scientific Enroute Transcarotid Neuroprotection System Plus and Boston Scientific Enroute Transcarotid Neuroprotection System (2 items)

Boston Scientific, sold nationwide

Why: Potential for arterial sheath tip separation or partial tip separation during use.

Class I: could cause serious harm or death

Carbamazepine Tablets

Golden State Medical Supply, sold nationwide

Why: CGMP deviations: tablets with black specks.

Class II: could cause temporary or reversible harm

About 420,000 people in the US are prescribed carbamazepine each year.

Carbamazepine Tablets

Sun Pharmaceutical Industries, sold nationwide

Why: CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Class II: could cause temporary or reversible harm

About 420,000 people in the US are prescribed carbamazepine each year.

Bmc/Reacthealth Luna G3 Apap Ref Lg

Bmc Medical Co.

Why: Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

Class I: could cause serious harm or death

Bd Needle Kit for Powered Driver

Bard Access Systems

Why: After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove...

Class I: could cause serious harm or death

Overstitch Suture Cinch and Suture Cinch Long (2 items)

Boston Scientific, sold nationwide

Why: Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

Class II: could cause temporary or reversible harm

Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers:

Convatec, sold nationwide

Why: Urostomy Pouches may leak from cap during use.

Class II: could cause temporary or reversible harm

Pemetrexed Disodium (2 products)

Shilpa Medicare Limited, sold nationwide

Why: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

Class II: could cause temporary or reversible harm

Cemiplimab-Rwlc

Regeneron Pharmaceuticals, sold nationwide

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

One-Piece Guedel Airway (2 items)

Intersurgical, sold nationwide

Why: Devices could potentially be occluded or partially occluded.

Class II: could cause temporary or reversible harm

Acamprosate Calcium Enteric-Coated

Mylan Pharmaceuticals, sold nationwide

Why: Failed Dissolution Specifications

Class II: could cause temporary or reversible harm

Halyard Lavh Pack

Avid Medical, sold nationwide

Why: The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.

Class II: could cause temporary or reversible harm

Beckman Coulter and Syva Emit (2 items)

Siemens Healthcare Diagnostics, sold nationwide

Why: Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment...

Class II: could cause temporary or reversible harm

Blanketrol Ii Model and Blanketrol Iii and 1 more (3 items)

Gentherm Medical, sold nationwide

Why: Overheating of the 115V CPU board may cause the device to shut down.

Class II: could cause temporary or reversible harm

Veritas Standard Glenoid Baseplate

Restor3d, sold nationwide

Why: Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

Class II: could cause temporary or reversible harm

Paragonix Technologies Inc. Kidneyvault Portable Renal Perfusion System Ref# Pr

Paragonix Technologies, sold nationwide

Why: Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.

Class II: could cause temporary or reversible harm

Td Navio Midi Speech Generating Device Model/Catalog Number: and Td Navio Maxi Speech Generating Device Model/Catalog Number: (2 items)

Tobii Dynavox, sold nationwide

Why: Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and...

Class II: could cause temporary or reversible harm

Hamilton Microlab Star Liquid Handler

Foundation Medicine, sold nationwide

Why: Software issue that can cause an increase in spontaneous software closures.

Class II: could cause temporary or reversible harm

Cardiac Workstation (2 items)

Philips North America, sold nationwide

Why: Device will intermittently provide inaccurate data related to native heart rate.

Class II: could cause temporary or reversible harm

Siemens Healthineers Immulite (2 items)

Siemens Healthcare Diagnostics Products, sold nationwide

Why: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

Class II: could cause temporary or reversible harm

Endoflip System That Includes: Endoflip

Covidien, sold nationwide

Why: The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.

Class II: could cause temporary or reversible harm

Beckman Coulter Dxc (2 items)

Beckman Coulter, sold nationwide

Why: a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a...

Class II: could cause temporary or reversible harm

Fort Defiance Industries

Fort Defiance Industries, sold nationwide

Why: The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.

Class II: could cause temporary or reversible harm

Arrow-Lok Implant

Arrowhead De, sold nationwide

Why: Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.

Class II: could cause temporary or reversible harm

Getinge Y Sensor Module

Maquet Critical Care Ab, sold nationwide

Why: The module did not undergo electrical safety tests and functional tests during production.

Class II: could cause temporary or reversible harm

American Contract Systems Medical Procedure Kits and Trays Labeled As: (2 items)

American Contract Systems

Why: The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected...

Class II: could cause temporary or reversible harm

Arvis Surgical Navigation System Gen

Kico Knee Innovation

Why: Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

Class II: could cause temporary or reversible harm

Minimed (3 items)

Medtronic Minimed

Why: Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing...

Class II: could cause temporary or reversible harm

Lago X and Ami Htx (2 items)

Spectral Instruments

Why: Momentary absence of On-Screen "X-Ray On" banner during run readiness check.

Class II: could cause temporary or reversible harm

Dentsply Sirona Capsule Mixer Model No.

Sdi Limited

Why: Potential for electrical discharge from unit when unplugged.

Class II: could cause temporary or reversible harm

Custom Made Device Implant (2 items)

Paragon 28, sold nationwide

Why: Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

Class III: unlikely to cause harm

Semaglutide (11 products)

Apollo Care, sold nationwide

Apollo Care recalled semaglutide 7.5 mg, 12.5 mg, 2.25 mg and 2.5 mg sterile multi-dose vials (1.5, 5 or 2.5 mL) after finding foreign particles. Lots AC-017273, AC-017108 and other lots, expiring 8/30/2026 to 5/5/2027, were sold nationwide.

FDA reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Class II: could cause temporary or reversible harm

About 8.3 million people in the US are prescribed semaglutide each year.

Sildenafil Citrate USP and Tadalafil USP (5 products)

Shoolin Pharma Chem L, sold nationwide

Why: CGMP Deviations:Noted during FDA inspection

Class II: could cause temporary or reversible harm

About 1.4 million people in the US are prescribed tadalafil each year.

Glutathione

Victory Medical Center Pharmacy, sold nationwide

Why: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Class I: could cause serious harm or death

About 300,000 people in the US are prescribed ascorbic acid each year.

Clindamycin Palmitate Hydrochloride

Heritage Pharmaceuticals, sold nationwide

Why: Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

Class II: could cause temporary or reversible harm

About 2.6 million people in the US are prescribed clindamycin each year.

Valsartan

Novartis Pharmaceuticals, sold nationwide

Why: Failed Dissolution Specifications

Class II: could cause temporary or reversible harm

About 2.6 million people in the US are prescribed valsartan each year.

Cefazolin in Dextrose

Baxter Healthcare, sold nationwide

Why: Presence of Particulate Matter

Class I: could cause serious harm or death

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter

Baxter Healthcare, sold nationwide

Why: Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.

Class I: could cause serious harm or death

Ioversol

Liebel-Flarsheim Company, sold nationwide

Why: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

Class I: could cause serious harm or death

Cardinal Health Presource Kits: (8 items)

Cardinal Health 200, sold nationwide

Why: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Class II: could cause temporary or reversible harm

V-Loc and Surgipro Ii S8698gx Surgipro Ii Bl and 2 more (5 items)

Covidien, sold nationwide

Why: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or...

Class II: could cause temporary or reversible harm

Kian Pee Wan Capsules

Buy-Herbal

Why: Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.

Class I: could cause serious harm or death

Medline Micro-Kill Bleach Germicidal Bleach Wipes (4 items)

Medline Industries, sold nationwide

Why: Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may...

Class II: could cause temporary or reversible harm

Sodium Chloride Injection

Spectra Medical Devices

Why: Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This...

Class I: could cause serious harm or death

Boston Scientific Enhance Transcarotid/Peripheral Access Kit Ref: SR-4f21g7d-Mp

Galt Medical, sold nationwide

Why: Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

Class II: could cause temporary or reversible harm

Obp Medical

Obp Medical, sold nationwide

Why: There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.

Class II: could cause temporary or reversible harm

Clear Eyes Maximum Itchy Eye Relief

Prestige Brands Holdings, sold nationwide

Why: Lack of assurance of sterility. The recall is due to potential contamination

Class II: could cause temporary or reversible harm

Gore Viabil Short Wire Biliary Endoprosthesis (2 items)

W L Gore & Associates, sold nationwide

Why: 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

Class II: could cause temporary or reversible harm

Bobby Balloon Guide Catheter Ref: Bob-895-Cn Bob-895-Emea Bob-895-Emea-Al B

Microvention, sold nationwide

Why: Due to an increase rate of balloon pinhole defects.

Class II: could cause temporary or reversible harm

Allura Xper Fd. Model Numbers:

Philips Medical Systems Nederland B.V., sold nationwide

Why: Firmware issue potentially leading to loss of geometry movements.

Class II: could cause temporary or reversible harm

Glidesheath Slender A-Kit

Terumo Medical, sold nationwide

Why: Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

Class II: could cause temporary or reversible harm

Navify Digital Pathology

Ventana Medical Systems, sold nationwide

Why: Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window

Class II: could cause temporary or reversible harm

Thermo Fisher Diagnostics Neisseria Meningitidis Gp C

Remel Europe, sold nationwide

Why: Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.

Class II: could cause temporary or reversible harm

Erbecryo

Erbe USA, sold nationwide

Why: A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive...

Class II: could cause temporary or reversible harm

Straumann Bone Level Tapered

Straumann USA, sold nationwide

Why: Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.

Class II: could cause temporary or reversible harm

Xhibit Central Station

Spacelabs Healthcare, sold nationwide

Why: Due to off-the-shelf display port component that has audio/video failures

Class II: could cause temporary or reversible harm

60 in Non-Dehp Minibore Extension Set Res Me2010 Udi-Di Code:

Bd Switzerland Sarl

Why: Products may not have received adequate sterilization processing.

Class II: could cause temporary or reversible harm

Gm Helix Implant

Straumann USA, sold nationwide

Why: There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or...

Class II: could cause temporary or reversible harm

Biofire Respiratory Panel

Biofire Diagnostics, sold nationwide

Why: Due to increase in false negative results

Class II: could cause temporary or reversible harm

Philips Azurion Rystem

Philips Medical Systems Nederland B.V.

Why: Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of...

Class II: could cause temporary or reversible harm

Philips Azurion

Philips Medical Systems Nederland B.V.

Why: Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to...

Class II: could cause temporary or reversible harm

Endo-Model

Waldemar Link Gmbh & Co. Kg (Mfg Site)

Why: The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be...

Class II: could cause temporary or reversible harm

Pronephro Aki

Bioporto Diagnostics A/S

Why: The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.

Class II: could cause temporary or reversible harm