Recall: D-0497-2026

Class II - Potentially Harmful

Class IIClassification

2026-04-02Initiated

OngoingStatus

B BRAUN MEDICAL INCFirm

Product

0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.

Reason

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Distribution

US Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.