Drug lookup, recalls and shortages

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

Shanghai United Imaging Healthcare Co.

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

Mr and Smartpath To Dstream for and 4 more (7 items)

Philips North America

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

Apheresis Platelets

Lifesouth Community Blood Centers

Why: Leukoreduced Apheresis Platelets product, for which platelet yield did not meet specifications, was distributed.

Class II: could cause temporary or reversible harm

Apheresis Platelets (2 items)

Lifesouth Community Blood Centers

Why: Leukoreduced Apheresis Platelets product, for which platelet yield did not meet specifications, was distributed.

Class II: could cause temporary or reversible harm

Apheresis Platelets (2 items)

Lifesouth Community Blood Centers

Why: Leukoreduced Apheresis Platelets product, for which platelet yield did not meet specifications, was distributed.

Class II: could cause temporary or reversible harm

Apheresis Platelets

Lifesouth Community Blood Centers

Why: Apheresis Platelets, Leukocytes Reduced, Irradiated product, for which platelet yield did not meet specifications, was distributed.

Class II: could cause temporary or reversible harm

Apheresis Platelets

Lifesouth Community Blood Centers - Montgomery Region

Why: Apheresis Platelets, Leukocytes Reduced, Irradiated product, for which platelet yield did not meet specifications, was distributed.

Class II: could cause temporary or reversible harm

Cornea

Eversight Illinois

Why: Corneas, recovered from a donor in which donor eligibility was not adequately determined, were distributed.

Class II: could cause temporary or reversible harm

Cornea

Visiongift

Why: Cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and...

Class II: could cause temporary or reversible harm

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

Alere San Diego

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

Embosphere

Merit Medical Systems

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

Encor Encompass Breast Biopsy and Tissue Removal System Console

Bard Peripheral Vascular

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

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

Heraeus Medical Gmbh (Dental Division)

Why: Potential for monomer liquid leakage.

Class II: could cause temporary or reversible harm

Philips Intrasight Plus Ref:

Volcano

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

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

American Nitrile Operations

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

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

American Contract Systems

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

Presource Packs Containing Stryker Strykeflow Ps and Ahto Tube Sets: 1) Kit (4 items)

Cardinal Health 200

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

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

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

Noxbox

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

Class II: could cause temporary or reversible harm

Ingenia Blue Seal Se and Blue Seal Xe and Ingenia and 1 more (4 items)

Philips North America

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

Ingenia Elition S and Ingenia Elition X.

Philips North America

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

Ranolazine Extended-Release Tablets

Ajanta Pharma USA

Why: Failed Dissolution Specifications

Not Yet Classified

Cornea

Saving Sight

Why: Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately...

Class III: unlikely to cause harm

Heartsine Samaritan Pad

Heartsine Technologies

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

Medline Convenience Kits: 1) Peds Sinus Pack and Medline Convenience Kits: 1) Major Pack and 3 more (5 items)

Medline Industries

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

Lemon Alfredo Fettuccine Packed in A Yellow Plastic Sealed Bag with Pink and Bla

Gias Food

Why: Contamination with Listeria monocytogenes

Class I: could cause serious harm or death

Red Blood Cells

Hcsc-Blood Center

Why: Red Blood Cells, Leukocytes Reduced, Irradiated, collected from a donor for whom donor eligibility screening was incomplete, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

Hcsc-Blood Center

Why: Red Blood Cells, Leukocytes Reduced, collected from a donor for whom donor eligibility screening was incomplete, were distributed.

Class II: could cause temporary or reversible harm

Pf24 Plasma

Hcsc-Blood Center

Why: PF24 Plasma, collected from a donor for whom donor eligibility screening was incomplete, were distributed.

Class II: could cause temporary or reversible harm

Apheresis Red Blood Cells

Oneblood

Why: Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated, which were labeled as leukocytes reduced but were not tested to verify white blood cell count, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

Lifestream Blood Bank

Why: Leukoreduced Red Blood Cells product, which was labeled as leukocytes reduced but was not tested to verify white blood cell count, was distributed.

Class II: could cause temporary or reversible harm

Apheresis Platelets

West Tn Regional Blood Center

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

Class II: could cause temporary or reversible harm

Apheresis Platelets

New York Blood Center

Why: Leukoreduced Apheresis Platelets products, with a platelet count higher than was acceptable, were distributed.

Class II: could cause temporary or reversible harm

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

Baxter Healthcare

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

Red Blood Cells

Blood Assurance

Why: Leukoreduced Red Blood Cells product, not labeled with a tag indicating that it contained antibodies, was distributed.

Class III: unlikely to cause harm

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

Boston Scientific

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

Halyard IV Start Kit Non-Sterile

Avid Medical

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

Red Blood Cells

Hcsc-Blood Center

Why: Red Blood Cells, Leukocytes Reduced, collected from a donor for whom donor eligibility screening was incomplete, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

Hcsc-Blood Center

Why: Red Blood Cells, Leukocytes Reduced, Irradiated, collected from a donor for whom donor eligibility screening was incomplete, were distributed.

Class II: could cause temporary or reversible harm

Pf24 Plasma

Hcsc-Blood Center

Why: PF24 Plasma, collected from a donor for whom donor eligibility screening was incomplete, was distributed.

Class II: could cause temporary or reversible harm

Volara

Baxter Healthcare

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

Cardioroot Woven Collagen Coated Vascular Graft

Intervascular, Sas

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

Class II: could cause temporary or reversible harm

New York Embroidery Studio Trinity Non-Surgical Isolation Gown

New York Embroidery Studio

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

Class II: could cause temporary or reversible harm

Halyard IV Start Kit Non-Sterile (2 items)

Avid Medical

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

Clear Eyes Redness Relief (2 products)

Insight Pharmaceuticals LLC, A Prestige Consumer Healthcare

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

0.9% Sodium Chloride Injection

Otsuka Icu Medical

Why: Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP but the actual product within the overwrap may be POTASSIUM...

Not Yet Classified

Pooled Cryoprecipitated Ahf

Impactlife

Why: Pooled Cryoprecipitated AHF, not prepared in accordance with specifications, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

the Blood Connection

Why: Red Blood Cells, Leukocytes Reduced, collected from a donor who had taken the drug Accutane, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

the Blood Connection

Why: Red Blood Cells, Leukocytes Reduced, collected from a donor currently taking Proscar, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

the National American Red Cross

Why: Red Blood Cells, Leukocytes Reduced, which were labeled as antigen negative, but were collected from a donor who subsequently tested antigen positive, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

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

Why: Misbranded Red Blood Cells, Leukocytes Reduced, Irradiated, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

Penn State Health Holy Spirit Medical Center

Why: Red Blood Cells, Leukocytes Reduced, with incomplete testing, were distributed.

Class II: could cause temporary or reversible harm

Bone

Tissue Transplant Technology

Why: Bone products, processed in a manner that could cause contamination, cross-contamination, or the introduction, transmission, or spread of communicable disease, were distributed.

Class II: could cause temporary or reversible harm

Cornea

Lions Eye Bank of Nebraska

Why: Corneas, recovered from a donor in which donor eligibility was not adequately determined, were distributed.

Class II: could cause temporary or reversible harm

Cornea

San Antonio Eye Bank

Why: Mislabeled cornea was distributed.

Class II: could cause temporary or reversible harm

Cornea

Onelegacy

Why: Corneas, recovered from a donor in which donor eligibility was not adequately determined, were distributed.

Class II: could cause temporary or reversible harm

Cornea

Eversight Illinois

Why: Cornea, recovered from a donor in which donor eligibility was not adequately determined, was distributed.

Class II: could cause temporary or reversible harm

Cornea

Onelegacy

Why: Corneas, recovered from donors in which donor eligibility was not adequately determined, were distributed.

Class II: could cause temporary or reversible harm

Ngenuity Patient Monitor with Capnography

Criticare Technologies

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

Presource Convenience Kits: 1) Kit (2 items)

Cardinal Health 200

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

Ref:

Deroyal Industries

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

Exenatide Injection

Amneal Pharmaceuticals of New York

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

Class II: could cause temporary or reversible harm

Red Blood Cells

Carter Bloodcare

Why: Red Blood Cells, Leukocytes Reduced, which were leukoreduced by filtration at an unacceptable temperature, were distributed.

Class III: unlikely to cause harm

Apheresis Platelets

the American National Red Cross South Carolina Region

Why: Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced, which were out of monitored storage for an extended period of time, were distributed.

Class III: unlikely to cause harm

Red Blood Cells

the American National Red Cross South Carolina Region

Why: Red Blood Cells, Leukocytes Reduced, which were out of monitored storage for an extended period of time, were distributed.

Class III: unlikely to cause harm

Cornea

South Dakota Lions Eye Bank

Why: Corneas, recovered from a donor who was not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.

Class III: unlikely to cause harm

Olanzapine Tablets

Macleods Pharmaceuticals Limited

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

Class III: unlikely to cause harm

Avkare Carboxymethylcellulose Sodium Ophthalmic Solution and Reliable -1 Laboratories and 6 more (9 products)

Sterling Pharmaceutical Services

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

Cornea

Eversight Illinois

Why: Cornea, processed without conducting the proper antibiotic soak, was distributed.

Class II: could cause temporary or reversible harm

Apheresis Platelets

Lifesouth Community Blood Centers

Why: Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced product, for which platelet yield did not meet specifications, was distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

Mississippi Blood Services

Why: Red Blood Cells, Leukocytes Reduced, collected from an unsuitable donor due to a donor screening deviation, was distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

Mississippi Blood Services

Why: Leukoreduced Red Blood Cells products, collected from a donor with hemoglobin lower than was acceptable, or who had no hemoglobin check performed during screening, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

Department of Defense - Air Force

Why: Red Blood Cells product, collected from a donor who previously tested repeatedly reactive for the antibody to Human T-Lymphotropic Virus (HTLV-I), was distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

the Blood Center

Why: Red Blood Cells, Leukocytes Reduced, incorrectly labeled as irradiated, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

Vitalant

Why: Red Blood Cells, Leukocytes Reduced, collected from a donor who provided travel history to a malaria endemic area, but was not assessed for residency, were distributed.

Class II: could cause temporary or reversible harm

Apheresis Platelets

the American National Red Cross

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

Class II: could cause temporary or reversible harm

Whole Blood

Department of Defense - Navy

Why: Whole Blood, which tested negative for the antibody to the Human T-Lymphotropic Virus (Anti-HTLV) but was collected from a donor who previously tested repeatedly reactive for anti-HTLV, Western blot positive, was...

Class II: could cause temporary or reversible harm

Red Blood Cells

Arup Laboratories

Why: Red Blood Cells, Leukocytes Reduced, collected from a donor taking an unlicensed, unapproved, or experimental medication, were distributed.

Class II: could cause temporary or reversible harm

Cornea

Corneagen - Boston

Why: Corneas, recovered from a donor in which donor eligibility was not adequately determined, were distributed.

Class II: could cause temporary or reversible harm

Cornea (2 items)

Precision Ocular Network - Bartlett

Why: Corneas, recovered from a donor in which donor eligibility was not adequately determined, were distributed.

Class II: could cause temporary or reversible harm

Cornea

Eversight

Why: Cornea, recovered from a donor in which donor eligibility was not adequately determined, was distributed.

Class II: could cause temporary or reversible harm

Cornea

Rocky Mountain Lions Eye Bank

Why: Corneas, recovered from donors in which donor eligibility was not adequately determined, were distributed.

Class II: could cause temporary or reversible harm

Cornea

Onelegacy

Why: Corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and...

Class II: could cause temporary or reversible harm

Cornea

Corneagen - Boston

Why: Corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and...

Class II: could cause temporary or reversible harm

Cornea

Iowa Lions Eye Bank

Why: Corneas, processed using an expired viewing chamber, were distributed.

Class II: could cause temporary or reversible harm

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

Becton, Dickinson and

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

Automated Impella Controller

Abiomed

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

Apheresis Platelets

Hcsc-Blood Center

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

Class III: unlikely to cause harm

Cornea

Eversight Illinois

Why: Corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.

Class III: unlikely to cause harm

Inca (2 items)

Coopersurgical

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

Achieva and Achieva XR and 7 more (12 items)

Philips North America

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

Evergreen Fresh Sprouts LLC

Evergreen Fresh Sprouts

Why: Salmonella

Class I: could cause serious harm or death

Spectralis with Flex Module

Heidelberg Engineering Gmbh

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

Olympus Bicoag Hemostasis Probe (4 items)

Olympus Corporation of the Americas

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

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

Midmark Iqvitals Zone (4 items)

Midmark

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

Hf2p0st9 Homefill Oxygen System Homefill Cylinder M9 with Cga870 Compatible Post and Ref:Hf2pc9 Homefill Oxygen System and 1 more (3 items)

Ventec Life Systems

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

Class II: could cause temporary or reversible harm

Extended Polyaxial Head

Seaspine Orthopedics

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

Class II: could cause temporary or reversible harm

Powerled

Maquet Sas

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

Combiset Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer

Fresenius Medical Care Renal Therapies Group

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

Philips Epiq Elite Diagnostic Ultrasound System Model #

Philips Ultrasound

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

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

Medline Industries

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

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

Coopervision

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

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

Pecorino Toscano D.O.P. Stagionato Cheese Wheels. Product of Italy. Each Cheese

Elegant Foods

Why: Potential Listeria contamination from dripping condensation in cooler.

Class II: could cause temporary or reversible harm

Mon Sire Brie

Optimus Inc. D/B/A/ Markys Caviar

Why: The firm was notified by their Brie Cheese supplier that sample results revealed the presence of Listeria monocytogenes.

Class I: could cause serious harm or death

Reign Medical Clench Staple System

F & A Foundation

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

Cadd Yellow Medication Cassette Reservoir with Nrfit Connector US Product Codes:

Icu Medical

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

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

Pi Cardia

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

Class II: could cause temporary or reversible harm

Dopamine HCL Inj.

Pfizer

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

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

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

Abiomed

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

Haylard and Haylard Continuous Nerve Block Tray 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

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

Pico De Gallo-Mild-4oz Pico De Gallo-Mild-6/14oz Pico De Gallo-4/5# Pico De Gall and Soup Mix-6/58oz Tray and 6 more (8 items)

Naturebest Pre-Cut & Produce

Why: Jalapenos have the potential to be contaminated with Salmonella

Class I: could cause serious harm or death

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

Axle Pin Assy Large Elbow Cobalt Chrome Catalog No. C-M112-2-500 Orthopaedic Imp and Omnifit Series I Acet. Insert and 10 more (12 items)

Howmedica Osteonics

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

Ref:2b5lt Ethicon Endo-Surgery and Ref:2b5st Ethicon Endo-Surgery and 4 more (6 items)

Stryker Sustainability Solutions

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

Class II: could cause temporary or reversible harm

Organic Triple Berry Blend Strawberries

Frutas Y Hortalizas Del Sur S.A.

Why: Potential E. coli O145:H28 Contamination

Class I: could cause serious harm or death

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).

Not Yet Classified

Red Blood Cells

American National Red Cross (the)

Why: Red Blood Cells, Leukocytes Reduced, Irradiated, collected in a manner that compromises the sterility of the collection system, were distributed.

Class II: could cause temporary or reversible harm

Pf24 Plasma

American National Red Cross (the)

Why: PF24 Plasma, collected in a manner that compromises the sterility of the collection system, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

American National Red Cross (the)

Why: Red Blood Cells, Leukocytes Reduced, collected in a manner that compromises the sterility of the collection system, were distributed.

Class II: could cause temporary or reversible harm

Hemospray Endoscopic Hemostat

Wilson-Cook Medical

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

Kinos Axiom Total Ankle System with Axiom Psr

Restor3d

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

Ewo_02512 and Ewo_02513 (2 items)

Embecta Medical Ii

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

Blood Culture Collection Venipuncture Kit

Medical Action Industries, Inc. 306

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

Boston Scientific Corporation Stonesmart Connect Console Contents:

Boston Scientific

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

Aisys and Aisys Cs2 and 2 more (4 items)

Datex-Ohmeda

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

Convenience Kits Anesthesia Pain Pk League Dynj67925a and Convenience Kits Minor Pack Dynj58421a Springhill Minor Pack Dynj40734f and 2 more (4 items)

Medline Industries

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

Captus

Mirion Technologies (Capintec)

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

Chlorthalidone Tablets

Inventia Healthcare Limited

Why: Failed Dissolution Specifications

Class II: could cause temporary or reversible harm

Povidone Iodine

Imprimisrx Nj, sold nationwide

Why: Subpotent Drug

Class III: unlikely to cause harm

Bd Alaris Pump Infusion Sets 10561554*

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

Diced Jalapenos. Ingredients: Jalapeno Pepper. Net Wt: and Rice & Bean Burrito. Ingredients: Rice and 21 more (25 items)

Taylor Fresh Foods

Why: Potential contamination with Salmonella.

Class I: could cause serious harm or death

Centricity Enterprise Archive V2 and Enterprise Archive V8 and 4 more (6 items)

Ge Healthcare

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

Red Blood Cells

the American National Red Cross

Why: Red Blood Cells, Leukocytes Reduced, collected from a donor who previously tested reactive for the antibody to Hepatitis B core antigen (anti-HBc) on more than one occasion, were distributed.

Class II: could cause temporary or reversible harm

Pooled Cryoprecipitated Ahf

the American National Red Cross

Why: Pooled Cryoprecipitated AHF, collected from a donor who previously tested reactive for the antibody to Hepatitis B core antigen (anti-HBc) on more than one occasion, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

American Natl. Red Cross-Greater Chesapeake & Potomac Region

Why: Red Blood Cells, Leukocytes Reduced, collected from a donor who provided travel history to a malaria endemic area, but was not assessed for residency, were distributed.

Class II: could cause temporary or reversible harm

Apheresis Pf24rt24 Plasma

American National Red Cross Blood Services Sw Region

Why: Apheresis PF24RT24 Plasma, collected in a manner that compromises the sterility of the collection system, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

Innovative Blood Resources

Why: Red Blood Cells, Leukocytes Reduced, collected from a donor who previously tested reactive for the antibody to Hepatitis B core antigen (anti-HBc) on more than one occasion, was distributed.

Class II: could cause temporary or reversible harm

Happiest Baby (2 items)

Happiest Baby

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

Noxboxi Nitric Oxide Delivery System.

Noxbox

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

Sunmed Tracheal Tube

Well Lead Medical Co.

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

Class II: could cause temporary or reversible harm

Gm Helix Implant

Straumann USA

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

Rt Montecarlo

Ptw Freiburg

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

Nystatin Cream

Sun Pharmaceutical Industries

Why: Failed Stability Specifications

Class II: could cause temporary or reversible harm

Phytonadione Injectable Emulsion

Amneal Pharmaceuticals of New York

Why: Failed Impurities/Degradation Specifications

Not Yet Classified

Martina Brand Fresh Whole Mangoes

Panorama Produce Sales

Why: Product may be contaminated with Salmonella

Class II: could cause temporary or reversible harm

Medline Convenience Kits: 1) Kit Anesthesia L&D A- Line Set and Medline Convenience Kits: 1) Open Heart Adult and 5 more (7 items)

Medline Industries

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

Everything Sprouts and Calco Branded Alfalfa Sprouts and Everything Sprouts Zesty Garlic Mix and 2 more (4 items)

Everything Sprouts

Why: Sprouts may be contaminated with STEC E. coli and/or Salmonella.

Class I: could cause serious harm or death

Fluphenazine HCL Elixir (6 products)

Safecor Health

Why: Failed Stability Specifications

Class II: could cause temporary or reversible harm

Apheresis Platelets

Lifeshare Blood Center

Why: Apheresis Platelets, Leukocytes Reduced, with a platelet count higher than was acceptable, were distributed.

Class II: could cause temporary or reversible harm

Plasma Frozen

New York Blood Center Enterprises

Why: Plasma Frozen, collected in an expired collection kit, were distributed.

Class III: unlikely to cause harm

Red Blood Cells

New York Blood Center Enterprises

Why: Red Blood Cells, Leukocytes Reduced, Irradiated, collected in an expired collection kit, were distributed.

Class III: unlikely to cause harm

Red Blood Cells

New York Blood Center Enterprises

Why: Red Blood Cells, Leukocytes Reduced, collected in an expired collection kit, were distributed.

Class III: unlikely to cause harm

Liquid Plasma

New York Blood Center Enterprises

Why: Liquid Plasma, collected in an expired collection kit, was distributed.

Class III: unlikely to cause harm

Thyroid Tablets

Vitruvias Therapeutics

Why: Superpotent Drug

Class I: could cause serious harm or death

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

Nova Biomedical

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

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

Bard Access Systems

Why: Kits contain 0.9% Sodium Chloride ampules, recalled by the supplier, that have potentially compromised sterility. If ampules are used, this could lead to systemic infection, inflammatory responses, sepsis, thrombosis...

Class I: could cause serious harm or death

Plum Administration Sets and IV Sets with Drip Chambers (5 items)

Icu Medical

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. The presence...

Class II: could cause temporary or reversible harm

Foods Alive Organic Moringa Leaf Powder

Foods Alive

Why: Potential Salmonella contamination

Class I: could cause serious harm or death

IV Non-Dedicated Gravity Administration Sets with Drip Chambers and Oncology Sets with Drip Chambers (3 items)

Icu Medical

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

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

Philips North America

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

Class II: could cause temporary or reversible harm

Medline Convenience Kit: Open Heart A Pack

Medline Industries

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

Carescape Central Station Cscs V3 Mas800 Desktop Part Number

Ge Medical Systems Information Technologies

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

Percutaneous Insertion Kit (3 items)

Maquet Cardiopulmonary Gmbh

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

Class II: could cause temporary or reversible harm

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

Bayer Medical Care

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

Class II: could cause temporary or reversible harm

Lidocaine Ointment USP

Sun Pharma /Taro

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

0.9% Sodium Chloride Injection

B Braun Medical

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

Clindamycin Phosphate and Vasopressin in 0.9% Sodium Chloride and 8 more (17 products)

Baxter Healthcare, sold nationwide

Why: CGMP Deviations

Class II: could cause temporary or reversible harm

Trazodone Hydrochloride

Teva Pharmaceuticals USA, sold nationwide

Why: Presence of Foreign Tablets/Capsules

Class II: could cause temporary or reversible harm

Sodium Chloride

Baxter Healthcare

Why: Presence of particulate matter: Particulates identified as fiberglass

Class I: could cause serious harm or death

Glutathione

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

Trokendi XR

Supernus Pharmaceuticals, sold nationwide

Why: Failed dissolution specifications.

Class III: unlikely to cause harm

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

Chlorhexidine Gluconate

Sage Products, sold nationwide

Why: Cross Contamination with Other Products

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

Mycophenolate Mofetil

Mylan Pharmaceuticals, sold nationwide

Why: Failed Dissolution Specifications

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

Alfalfa

International Sprout Holdings

Why: Potential E. coli and Salmonella contamination

Class I: could cause serious harm or death

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

Epinephrine Injection

American Regent

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

Apheresis Platelets

Lifesouth Community Blood Centers - Montgomery Region

Why: Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced, for which platelet yield did not meet specifications, were distributed.

Class II: could cause temporary or reversible harm

Apheresis Platelets

the American National Red Cross South Carolina Region

Why: Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced, possibly exposed to unacceptable temperatures due to extended transit time, were distributed.

Class II: could cause temporary or reversible harm

Red Blood Cells

the American National Red Cross

Why: Red Blood Cells, Leukocytes Reduced, collected from donors whose arm inspections were not properly performed, were distributed.

Class III: unlikely to cause harm

Red Blood Cells

the American National Red Cross

Why: Red Blood Cells, Leukocytes Reduced, Irradiated, collected from donors whose arm inspections were not properly performed, were distributed.

Class III: unlikely to cause harm

Pf24 Plasma

the American National Red Cross

Why: PF24 Plasma, collected from donors whose arm inspections were not properly performed, were distributed.

Class III: unlikely to cause harm

Levothyroxine Sodium (12 products)

Accord Healthcare, sold nationwide

Why: Subpotent Drug

Class II: could cause temporary or reversible harm

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

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

Ibuprofen

Safecor Health

Why: Cross Contamination with Other Products

Not Yet Classified

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

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

Repository Corticotropin

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

Clobetasol Propionate

Lupin Pharmaceuticals, sold nationwide

Why: Failed content uniformity specifications.

Class II: could cause temporary or reversible harm

Paxil Cr

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

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

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

Class I: could cause serious harm or death

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

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

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

Carbamazepine

Golden State Medical Supply, sold nationwide

Why: CGMP deviations: tablets with black specks.

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

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

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

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

Class II: could cause temporary or reversible harm

Valsartan

Novartis Pharmaceuticals, sold nationwide

Why: Failed Dissolution Specifications

Class II: could cause temporary or reversible harm

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

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

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

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

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

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

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

Halyard Convenience Kits Containing Recalled Medline Namic Angiographic Star Off (3 items)

Avid Medical, sold nationwide

Why: Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path...

Class I: could cause serious harm or death

Cyclophosphamide for Injection (2 products)

Sunny Pharmtech, sold nationwide

Why: Presence of Particulate Matter; identified as stainless steel

Class I: could cause serious harm or death

Stryker Ahto Dual Spike Tube Set Packaging and Stryker Ahto Tube Set Packaging and 2 more (5 items)

Stryker, sold nationwide

Why: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Class II: could cause temporary or reversible harm

Q6 Edge and Quantum Outback and 5 more (13 items)

Pride Mobility Products, sold nationwide

Why: If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected...

Class II: could cause temporary or reversible harm

Infinion Cx Lead Kit

Boston Scientific Neuromodulation

Why: Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention...

Class I: could cause serious harm or death

Charger for the Therabody Theragun

Therabody, sold nationwide

Why: Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire). Firm has received reports alleging the product caught fire and other reports...

Class II: could cause temporary or reversible harm

Radial Jaw (3 items)

Boston Scientific, sold nationwide

Why: Potential for breach in sterile barrier of device packaging.

Class II: could cause temporary or reversible harm

Coaptium Connect (8 items)

Tissium Sa, sold nationwide

Why: Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may...

Class II: could cause temporary or reversible harm

Flow Anesthesia Machine Flow-I C20

Maquet Critical Care Ab, sold nationwide

Why: Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to...

Class II: could cause temporary or reversible harm

Dicyclomine Hydrochloride

Aurobindo Pharma USA, sold nationwide

Why: shortfill; reports of empty capsules.

Class II: could cause temporary or reversible harm

Mirabegron

Zydus Pharmaceuticals (USA), sold nationwide

Why: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

Class II: could cause temporary or reversible harm

Femoral Valgus Adaptor and Psa Box Trial and 2 more (4 items)

United Orthopedic, sold nationwide

Why: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

Class II: could cause temporary or reversible harm

Atellica Ch Urine Albumin Ref:

Siemens Healthcare Diagnostics, sold nationwide

Why: Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results...

Class II: could cause temporary or reversible harm

Mc2 Portable X-Ray System

Oxos Medical, sold nationwide

Why: Due to a defective circuit board that overheats

Class II: could cause temporary or reversible harm

Forward Oral Airway Kit and Kingfisher Compact Individual First Aid Kit. Ref Number: (2 items)

Integrated Medcraft, sold nationwide

Why: Devices could potentially contain an occluded or partially occluded Guedel Airway tip.

Class II: could cause temporary or reversible harm

Ge Healthcare Mac Vu360

Ge Medical Systems Information Technologies, sold nationwide

Why: Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a...

Class II: could cause temporary or reversible harm

Ref # D23354 and Ref # D23352 (2 items)

Beckman Coulter, sold nationwide

Why: Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

Class II: could cause temporary or reversible harm

Blom-Singer Classic Indwelling Voice Prosthesis (2 items)

Freudenberg Medical, sold nationwide

Why: Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.

Class II: could cause temporary or reversible harm

Femoral Offset Bushing (2 items)

United Orthopedic, sold nationwide

Why: Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

Class II: could cause temporary or reversible harm

Happiest Baby

Happiest Baby, sold nationwide

Why: This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.

Class II: could cause temporary or reversible harm

Wasplab

Copan Wasp, sold nationwide

Why: Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.

Class II: could cause temporary or reversible harm

5-Plasma Bivalirudin Amr Verification Kit and 5-Plasma Bivalirudin Calibrator and 1 more (3 items)

Aniara Diagnostica, sold nationwide

Why: Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and...

Class II: could cause temporary or reversible harm

Gem Premier (2 items)

Instrumentation Laboratory, sold nationwide

Why: The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management...

Class II: could cause temporary or reversible harm

Anti-Torque

Innovasis, sold nationwide

Why: Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent...

Class II: could cause temporary or reversible harm

Nerivio Infinity. Model/Catalog Number: Fgd000100. Software Version: Fw Versio

Theranica Bioelectronics

Why: Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.

Class II: could cause temporary or reversible harm

Ge Healthcare Portrait Core Services Sw V

Ge Medical Systems Information Technologies, sold nationwide

Why: A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information...

Class II: could cause temporary or reversible harm

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: (5 items)

Biomet

Why: Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

Class II: could cause temporary or reversible harm

Munevo Drive and Munevo Drive R-Net Powered Wheelchair Hands-Free Control App

Munevo Gmbh, sold nationwide

Why: A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control while driving the wheelchair. The...

Class II: could cause temporary or reversible harm

Merge Pacs and Merge Orthopacs (2 items)

Merge Healthcare, sold nationwide

Why: Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

Class II: could cause temporary or reversible harm

Filmarray Ngds Warrior Panel Ref Ngds-Asy-0007 Udi-Di Code:

Biofire Defense, sold nationwide

Why: Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.

Class II: could cause temporary or reversible harm

Hardydisk Ast Cefiderocol

Hardy Diagnostics, sold nationwide

Why: Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy...

Class II: could cause temporary or reversible harm

Dialysis Change Tray Clear Sequence

Medical Action Industries, Inc. 306, sold nationwide

Why: Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.

Class II: could cause temporary or reversible harm

Dash Rapid Pcr Instrument

Nuclein, sold nationwide

Why: Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).

Class II: could cause temporary or reversible harm

Philips Allura and Philips Azurion Under the Following System Descriptions and Corresponding Model and 1 more (3 items)

Philips Medical Systems Nederland B.V., sold nationwide

Why: Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Class II: could cause temporary or reversible harm

Neuroguard Iep

Contego Medical, sold nationwide

Why: Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this...

Class II: could cause temporary or reversible harm

Remisol Advance with Software Version

Beckman Coulter Biomedical Gmbh

Why: Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.

Class II: could cause temporary or reversible harm

Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Smn

Siemens Healthcare Diagnostics, sold nationwide

Why: out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to...

Class III: unlikely to cause harm

Syva Emit Disopyramide Assay Enzyme Immunoassay

Siemens Healthcare Diagnostics, sold nationwide

Why: Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is...

Class III: unlikely to cause harm

Total Parental Nutrition - Pediatric Pn Patient-Specific Tpn Bag

Central Admixture Pharmacy Services

Why: Incorrect Product Formulation

Class III: unlikely to cause harm

Resmed Astral

Resmed, sold nationwide

Why: Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

Class I: could cause serious harm or death

Stryker Hoffmann Ii Connecting Rod Micro (7 items)

Stryker Gmbh, sold nationwide

Why: Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

Class II: could cause temporary or reversible harm

Eopa Elongated One-Piece Arterial Cannula Dil Tip and Eopa and 1 more (6 items)

Medtronic Perfusion Systems, sold nationwide

Why: Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ...

Class II: could cause temporary or reversible harm

Pack Angiography Ncmc

Medical Action Industries, Inc. 306

Why: Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within...

Class I: could cause serious harm or death

Ams Aligned Medical Solutions Medical Convenience Kits Labeled As: and Ams Aligned Medical Solutions Medical Convenience Kits Labeled As: Port Tray - and 4 more (8 items)

Windstone Medical Packaging, sold nationwide

Why: Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to...

Class II: could cause temporary or reversible harm

Gem Premier (6 items)

Instrumentation Laboratory, sold nationwide

Why: Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.

Class II: could cause temporary or reversible harm

Azelaic Acid

Glenmark Pharmaceuticals Inc., USA, sold nationwide

Why: CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

Class II: could cause temporary or reversible harm

Mycophenolate Mofetil

Mylan Pharmaceuticals, sold nationwide

Why: Presence of precipitate

Class II: could cause temporary or reversible harm

Dorzolamide Hydrochloride and Timolol Maleate

Micro Labs USA, sold nationwide

Why: Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.

Class II: could cause temporary or reversible harm

Ams Aligned Medical Solutions Medical Convenience Kits Labeled As: (4 items)

Windstone Medical Packaging, 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

Osteoballast

Isotis Orthobiologics, sold nationwide

Why: Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm...

Class II: could cause temporary or reversible harm

Power Over Fiber Base Module

Terex Utilities, sold nationwide

Why: Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for device. Improperly labeled - omitted...

Class II: could cause temporary or reversible harm

Iqon Spectral Ct Iqon Spectral Ct Upgrades and Brilliance Ict Brilliance Ict Upgrades Brilliance Ict Sp Brilliance Ct and 1 more (3 items)

Philips Medical Systems, sold nationwide

Why: The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being...

Class II: could cause temporary or reversible harm

Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock Ref:120031

Permobil, sold nationwide

Why: This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the wheelchair or the...

Class II: could cause temporary or reversible harm

M5 Corpus Power Wheelchair Ref

Permobil, sold nationwide

Why: This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an unstable condition in...

Class II: could cause temporary or reversible harm

L-Cath Midline S/L Catheter and L-Cath Picc S/L Peripherally Inserted Central Catheter: (2 items)

Argon Medical Devices

Why: Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may...

Class II: could cause temporary or reversible harm

Dabigatran Etexilate (3 products)

Ascend Laboratories, sold nationwide

Why: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

Class III: unlikely to cause harm

Levothyroxine Sodium (12 products)

Major Pharmaceuticals, sold nationwide

Why: Subpotent Drug

Class II: could cause temporary or reversible harm

Cetirizine Hydrochloride

Jb Chemicals and Pharmaceuticals, sold nationwide

Why: Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.

Class I: could cause serious harm or death

Amlodipine and Olmesartan Medoxomil

Ascend Laboratories, sold nationwide

Why: Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

Class II: could cause temporary or reversible harm

Naphazoline Hydrochloride, Polysorbate 80 and Hypromellose, Tetrahydrozoline Hydrochloride and 3 more (8 products)

Rohto-Mentholatum (Vietnam) Co., sold nationwide

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

Trokendi XR

Supernus Pharmaceuticals, sold nationwide

Why: Failed Dissolution Specifications

Class III: unlikely to cause harm

Ropivacaine Hydrochloride and Lidocaine Hydrochloride,Epinephrine Bitartrate and 2 more (5 products)

Fresenius Kabi USA, sold nationwide

Why: Presence of Particulate Matter: Hair was found in products

Class II: could cause temporary or reversible harm

Faradrive Steerable Sheath Clear and Faradrive Steerable Sheath Clear Ous and 2 more (4 items)

Boston Scientific, sold nationwide

Why: Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve...

Class II: could cause temporary or reversible harm

Medline Medical Procedure Convenience Kit Labeled As: and Medline Medical Procedure Convenience Kit Labeled As: Hip Cds-Lf (2 items)

Medline Industries

Why: The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.

Class I: could cause serious harm or death

Medline Anterior Hip and Medline Convenience Kits Labeled As: (3 items)

Medline Industries

Why: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their...

Class I: could cause serious harm or death

Cyproheptadine Hydrochloride

Rising Pharma Holding, sold nationwide

Why: Presence of Precipitate: medication was crystallizing and particles floating in the bottle

Class II: could cause temporary or reversible harm

Hotline Fluid Warming Set

Icu Medical, sold nationwide

Why: ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.

Class II: could cause temporary or reversible harm

Medline Convenience Kits Containing Bard¿ Silastic¿ Foley Catheters (9 items)

Medline Industries, sold nationwide

Why: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of...

Class II: could cause temporary or reversible harm

Divalproex Sodium

Bionpharma, sold nationwide

Why: Presence of Foreign Tablets/Capsules

Class II: could cause temporary or reversible harm

Glycopyrrolate

Precision Dose, sold nationwide

Why: Failed Impurities/Degradation Specifications

Class II: could cause temporary or reversible harm

Halyard Standard Line Insertion Pack. Model/Catalog Number: Pvhm234-01. Conv

Avid Medical, sold nationwide

Why: Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.

Class II: could cause temporary or reversible harm

Penumbra System Red

Penumbra, sold nationwide

Why: Due to manufacturing issues, reperfusion catheters may fractures

Class II: could cause temporary or reversible harm

Safeop Patient Interface

Alphatec Spine, sold nationwide

Why: Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication...

Class II: could cause temporary or reversible harm

Minimed Go App

Medtronic Minimed, sold nationwide

Why: For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This...

Class II: could cause temporary or reversible harm

Flexible Hystero-Fiberscope Kits Ref:

Karl Storz Endoscopy, sold nationwide

Why: Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.

Class II: could cause temporary or reversible harm

Power F2 Powered Fastening System

Ferno-Washington, sold nationwide

Why: Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and...

Class II: could cause temporary or reversible harm

Ventriculostomy Kit

Medtronic Neurosurgery, sold nationwide

Why: Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with...

Class II: could cause temporary or reversible harm

Pipeline Flex Embolization Device with Shield Technology (2 items)

Micro Therapeutics, sold nationwide

Why: Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.

Class II: could cause temporary or reversible harm

P28 Phanton Intramedullary Nail System

Paragon 28, sold nationwide

Why: Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

Class II: could cause temporary or reversible harm

the Intended Use Is To Be Paired with A Weapon for Aiming Purposes.

Wilcox Industries, sold nationwide

Why: Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change.

Class II: could cause temporary or reversible harm

Halyard Eye Pack. Model/Catalog Number: Lvey27 Convenience Kit.

Avid Medical, sold nationwide

Why: Incorrect concentration of Betadine solution contained within certain AVID convenience kits.

Class II: could cause temporary or reversible harm

Snapshotglo Wound Imaging Device

Kent Imaging, sold nationwide

Why: The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected...

Class II: could cause temporary or reversible harm

Olympus High Flow Insufflation Unit - Uhi-4. Model Number: Uhi-4

Olympus Corporation of the Americas, sold nationwide

Why: Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

Class II: could cause temporary or reversible harm

Boston Scientific Therasphere

Boston Scientific, sold nationwide

Why: Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose...

Class II: could cause temporary or reversible harm

Emano Flow with Software Version V2.0.0 Gs1 Gtin Code:

Emano Metrics, sold nationwide

Why: Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models...

Class II: could cause temporary or reversible harm

Seaspine Polyaxial Head Ref Number:

Seaspine Orthopedics, sold nationwide

Why: Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

Class II: could cause temporary or reversible harm

3mensio Workstation

Pie Medical Imaging B.V., sold nationwide

Why: User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur...

Class II: could cause temporary or reversible harm

Silent Nite Sleep Appliance

Prismatik Dentalcraft, sold nationwide

Why: Due to device not having FDA Clearance

Class II: could cause temporary or reversible harm

Olympus

Olympus Corporation of the Americas, sold nationwide

Why: Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.

Class II: could cause temporary or reversible harm

Farastar Ablation Generator Eu

Boston Scientific

Why: Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.

Class II: could cause temporary or reversible harm

Farastar Ablation Generator Eu and Farastar Pulsed Field Ablation Generator and 1 more (3 items)

Boston Scientific

Why: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Class II: could cause temporary or reversible harm

Medline Medical Convenience Kits Labeled As: and Medline Medical Convenience Kits Labeled As: Neuro Pack (4 items)

Medline Industries

Why: Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

Class II: could cause temporary or reversible harm

Dabigatran Etexilate (2 products)

Ascend Laboratories, sold nationwide

Why: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

Class III: unlikely to cause harm

Lidocaine, Kenalog, Povidone Iodine

Asclemed USA

Why: Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

Class III: unlikely to cause harm

Abiomed Impella Cp Set and Abiomed Impella Cp Introducer Kit and 6 more (13 items)

Abiomed, sold nationwide

Why: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or...

Class I: could cause serious harm or death

General Biospy Tray and Arterial Line Kit and 4 more (6 items)

Argon Medical Devices, sold nationwide

Why: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Class I: could cause serious harm or death

Carbamide Peroxide and Foster & Thrive (11 products)

Bell Pharmaceuticals, sold nationwide

Why: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Class II: could cause temporary or reversible harm

Abiomed Ref: (3 items)

Oscor

Why: Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

Class I: could cause serious harm or death

Chlorhexidine Gluconate and Isopropyl Alcohol

Carefusion 213, sold nationwide

Why: Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

Class II: could cause temporary or reversible harm

Nystatin

Padagis US, sold nationwide

Why: Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

Class II: could cause temporary or reversible harm

Rapid Refill Continuous Injection System

Boston Scientific, sold nationwide

Why: Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete...

Class II: could cause temporary or reversible harm

Clevipidine

Chiesi USA, sold nationwide

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

Papablic Replacement Brush Heads. Model Number: Papa317aa. and Papablic Replacement Brush Heads. Model Number: Papablic18b (2 items)

Papablic, sold nationwide

Why: Potential for brush heads to break.

Class II: could cause temporary or reversible harm

Icu Medical Plum Duo Infusion Pump and Icu Medical Plum Solo Precision IV Pump (2 items)

Icu Medical, sold nationwide

Why: In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

Class II: could cause temporary or reversible harm

Da Vinci Sp Instrument Arm Drape

Intuitive Surgical, sold nationwide

Why: Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result...

Class II: could cause temporary or reversible harm

Photera (3 items)

Daavlin Distributing, sold nationwide

Why: Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

Class II: could cause temporary or reversible harm

Optima Xr200amx and Optima Xr220amx and 1 more (3 items)

Ge Medical Systems, sold nationwide

Why: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly....

Class II: could cause temporary or reversible harm

Olympus Ellik Evacuator Includes Glass Body and Olympus Toomey Evacuator and 1 more (4 items)

Olympus Corporation of the Americas, sold nationwide

Why: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Class II: could cause temporary or reversible harm

St Aia-Pack Testosterone

Tosoh Bioscience, sold nationwide

Why: The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone...

Class II: could cause temporary or reversible harm

Medline Kits Containing Zimmer Biomet Mixing Bowls and Spatulas Total Knee Pa (2 items)

Medline Industries, sold nationwide

Why: Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant...

Class II: could cause temporary or reversible harm

Medtronic Bio-Medicus Adult Cannula Kit and Medtronic Dlp One-Piece Pediatric Arterial Cannula (2 items)

Medtronic Perfusion Systems, sold nationwide

Why: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

Class II: could cause temporary or reversible harm

the Vasoview Hemopro

Maquet Cardiovascular, sold nationwide

Why: Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its...

Class II: could cause temporary or reversible harm

Rio" Ii Nasal Pillows Interface

3b Medical, sold nationwide

Why: Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).

Class II: could cause temporary or reversible harm

Orthofix Minirail and Orthofix Articulated Minirail Fixator Horizontal Axis Ref: M111 (4 items)

Orthofix U.S.

Why: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

Class II: could cause temporary or reversible harm

Dimethicone

Biomed Laboratories, sold nationwide

Why: Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

Class II: could cause temporary or reversible harm

Olympus Single Use Distal Cover

Olympus Corporation of the Americas, sold nationwide

Why: Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

Class II: could cause temporary or reversible harm

5008x Blood Tubing Set

Fresenius Medical Care Holdings, sold nationwide

Why: Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.

Class II: could cause temporary or reversible harm

Gasco Isopropyl Alcohol and Drogueria San Juan Puerto Rico Isopropyl Alcohol (6 products)

Gasco Industrial, sold nationwide

Why: Subpotent drug

Class II: could cause temporary or reversible harm

Pemetrexed for Injection and Bortezomib for Injection and 1 more (4 products)

Reliance Life Sciences Private Limited, sold nationwide

Why: Lack of Sterility Assurance

Class II: could cause temporary or reversible harm

Atellica Ch Enzymatic Hemoglobin A1c

Siemens Healthcare Diagnostics, sold nationwide

Why: The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.

Class II: could cause temporary or reversible harm

Intracept Access Instruments

Boston Scientific Neuromodulation, sold nationwide

Why: Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.

Class II: could cause temporary or reversible harm

Methohexital Sodium

Onesource Specialty Pharma Limited, sold nationwide

Why: Failed Impurities/Degradation Specifications

Class II: could cause temporary or reversible harm

Methohexital Sodium

Quva Pharma, sold nationwide

Why: Failed Impurities/Degradation Specifications

Class II: could cause temporary or reversible harm

Aquacel AG Surgical Sp Ref:

Convatec, sold nationwide

Why: Surgical dressing manufactured out of specification (greater thickness).

Class II: could cause temporary or reversible harm

Gsp Neonatal Galt Kit. Product Codes:

Wallac Oy, sold nationwide

Why: Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.

Class II: could cause temporary or reversible harm

Kl Owen Custom Orthodontic Solution

Klowen Braces, sold nationwide

Why: A product error defect may cause incorrect bracket placement.

Class II: could cause temporary or reversible harm

Vesius Surgeon Console US

Cmr Surgical Limited, sold nationwide

Why: Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

Class II: could cause temporary or reversible harm

Medline Convenience Kits: (3 items)

Medline Industries, sold nationwide

Why: Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9...

Class II: could cause temporary or reversible harm

Fletcher Ct/Mr Shielded Applicator Set Product Name: Intracavitary Remote After and Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Produ and 1 more (3 items)

Elekta, sold nationwide

Why: Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

Class II: could cause temporary or reversible harm

Tmini Femur Tracking Array Ref

Think Surgical, sold nationwide

Why: Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.

Class II: could cause temporary or reversible harm

Vitek

Biomerieux

Why: Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.

Class II: could cause temporary or reversible harm

Omnitract Surgical Retractor System

Integra Lifesciences Corp. (Neurosciences), sold nationwide

Why: The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on...

Class II: could cause temporary or reversible harm

Clomiphene Citrate USP Active Pharmaceutical Ingredient

Shimoga Chemicals

Why: cGMP deviations

Class II: could cause temporary or reversible harm

Minimed

Medtronic Minimed

Why: A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53...

Class II: could cause temporary or reversible harm

Empowr (2 items)

Encore Medical

Why: Due to packaging discrepancy with incorrect product size mixed up.

Class II: could cause temporary or reversible harm

Levothyroxine Sodium

Accord Healthcare, sold nationwide

Why: Subpotent Drug

Class II: could cause temporary or reversible harm

Undecylenic Acid and Fungal Fusion Eradication Solution and 3 more (8 products)

Blaine Labs, sold nationwide

Why: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Class I: could cause serious harm or death

Omnipod and Omnipod Dash Pod. Includes the Below Model/Ref Numbers: (3 items)

Insulet, sold nationwide

Why: External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump...

Class I: could cause serious harm or death

Hillrom Volara System P.Circuit Kit Ac and Hillrom Volara System P.Circuit and 2 more (4 items)

Baxter Healthcare, sold nationwide

Why: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization...

Class I: could cause serious harm or death

Breathing Circuit Set

Hamilton Medical AG, sold nationwide

Why: Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result...

Class I: could cause serious harm or death

Chlorhexidine Gluconate and Isopropyl Alcohol and Povidone Iodine and Isopropyl Alcohol (10 products)

Carefusion 213, sold nationwide

Why: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Class II: could cause temporary or reversible harm

Synjardy XR Tablets

Boehringer Ingelheim Pharmaceuticals

Why: CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.

Class II: could cause temporary or reversible harm

Ck000495a Poly Midline Catheter and 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter and 12 more (14 items)

Bard Access Systems, sold nationwide

Why: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Class II: could cause temporary or reversible harm

Cre Pro Wireguided and Cre Wireguided (12 items)

Boston Scientific, sold nationwide

Why: Potential sterile breach of the pouches in which devices are packaged.

Class II: could cause temporary or reversible harm

A M S (4 items)

Windstone Medical Packaging, sold nationwide

Why: Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Class I: could cause serious harm or death

Medtronic Harmony Delivery Catheter System

Medtronic Heart Valves Division, sold nationwide

Why: Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a...

Class I: could cause serious harm or death

Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item No.

Medline Industries, sold nationwide

Why: Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk...

Class I: could cause serious harm or death

Prednisolone Acetate

Lupin Pharmaceuticals, sold nationwide

Why: Presence of Foreign Substance

Class II: could cause temporary or reversible harm

Medline Convenience Kits Containing Recalled Swan-Ganz Catheters Kit Germanto and Medline Convenience Kits Containing Recalled Swan-Ganz Catheters Cardiac Majo and 5 more (8 items)

Medline Industries, sold nationwide

Why: Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to...

Class II: could cause temporary or reversible harm

Pilling Wecksorb Neurosponges

Teleflex, sold nationwide

Why: Due to out-of-specification, or potential out-of-specification, levels of endotoxins

Class II: could cause temporary or reversible harm

Medline Convenience Kits: (15 items)

Medline Industries, sold nationwide

Why: The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent...

Class II: could cause temporary or reversible harm

Covidien Shiley Disposable Decannulation Plug Ref Ddcp Udi-Di Code:

Covidien, sold nationwide

Why: Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

Class II: could cause temporary or reversible harm

Glucagon

Lupin Pharmaceuticals, sold nationwide

Why: CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

Class II: could cause temporary or reversible harm

Cinacalcet (3 products)

Cipla USA, sold nationwide

Why: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Class II: could cause temporary or reversible harm

A.T.S¿ (2 items)

Zimmer Surgical, sold nationwide

Why: Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find...

Class II: could cause temporary or reversible harm

Lidocaine Hydrochloride and Lidocaine Hydrochloride Anhydrous (2 products)

Asclemed USA, sold nationwide

Why: Lack of Assurance of Sterility

Class II: could cause temporary or reversible harm

Ustekinumab-Srlf

Accord Biopharma, sold nationwide

Why: Lack of assurance of Sterility:

Class II: could cause temporary or reversible harm

Gemcitabine

Mckesson, sold nationwide

Why: Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

Class II: could cause temporary or reversible harm

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

Lannett Company, sold nationwide

Why: Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

Class II: could cause temporary or reversible harm

Gc Agar Base

Remel, sold nationwide

Why: Reduced or no recovery of some strains of Neisseria gonorrhoeae.

Class II: could cause temporary or reversible harm

Raycare (2 items)

Raysearch Laboratories Ab, sold nationwide

Why: Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.

Class II: could cause temporary or reversible harm

Radius Vsm Ecg Pre-Connected Set and Radius Vsm Disposable Nibp Cuff (2 items)

Masimo, sold nationwide

Why: Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians...

Class II: could cause temporary or reversible harm

Zeiss Intrabeam Spherical Applicator

Carl Zeiss Meditec AG, sold nationwide

Why: Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.

Class II: could cause temporary or reversible harm

Artis Icono Ceiling. Model Number:

Siemens Medical Solutions USA, sold nationwide

Why: Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.

Class II: could cause temporary or reversible harm

Enfit Exset Strl

Medela