FDA Drug · D-0495-2026

Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.

Class II · Ongoing

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

Affected lots / codes — check yours against thisLot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.

Recalling firm: B BRAUN MEDICAL INC, Allentown, PA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 24,928 bags
Distribution: US Nationwide.
Recall initiated: April 2, 2026
Classified: April 28, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0495-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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