Why it was recalled
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Product description
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.
Lot numbers, UPCs & expiration 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.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0497-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 2, 2026
- FDA report date
- Apr 29, 2026
- Quantity
- 124,244 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B BRAUN MEDICAL INC
Original FDA data
Every field from FDA enforcement report D-0497-2026, exactly as published.
Show all FDA fields
- City
- Allentown
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 98693
- Address
- 861 Marcon Blvd
- Code information
- 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.
- Postal code
- 18109-9577
- Report date
- Apr 29, 2026
- Product type
- Drugs
- Recall number
- D-0497-2026
- Classification
- Class II
- Recalling firm
- B BRAUN MEDICAL INC
- Product quantity
- 124,244 bags
- Reason for recall
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Apr 2, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 28, 2026