B BRAUN MEDICAL INC recalls 0.9 % SODIUM CHLORIDE IRRIGATION
- Recalling company
- B BRAUN MEDICAL INC
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 2, 2026
- Reported
- Apr 29, 2026
- Distribution
- US Nationwide.
- Status
- Ongoing
- Quantity
- 124,244 bags
- Lot / codes
- Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028.
- Company location
- Allentown, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0497-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0497-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.