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 24, 2026 at 12:00 AM UTC.

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