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FDAClass II · Drug · Recalled April 29, 2026
0 recall — B BRAUN MEDICAL INC
Hazard: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- D-0497-2026
- Brand
- B BRAUN MEDICAL
- Classification
- Class II
- Units affected
- 124,244 bags
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
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.
Affected products
Companies & origin
- Recalling firm location
- Allentown, PA, United States
- Firm address
- 861 Marcon Blvd, N/A, 18109-9577
Identifying details (verbatim from the notice)
- Product codes / lots
- 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.
- Distribution
- US Nationwide.
- Firm notified the public via
- Letter
- FDA event ID
- 98693
- Recall initiated
- April 2, 2026
- FDA classified
- April 28, 2026
- FDA report date
- April 29, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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