Medical devices
B. Braun tells customers to remove hemodialysis bloodline sets
B. Braun says a connector may detach or leak during dialysis, potentially causing blood loss or air to enter the blood circuit.
B. Braun Medical Inc. has advised affected customers to remove certain hemodialysis bloodline sets from use or sale, according to an FDA MedWatch alert.
B. Braun said a required solvent application step was missed during assembly, leaving the dialyzer connector inadequately bonded. The connector may detach or leak during priming or dialysis, potentially causing blood loss, clotting or air to enter the blood circuit. The FDA said treatment may need to be interrupted and the bloodline replaced. As of October 10, 2026, B. Braun had reported no serious injuries or deaths associated with the issue. The FDA is reviewing information and said it will update the alert as new information becomes available.


