FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Drug · Recalled April 29, 2026

Sterile Water for Injection USP 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-0495-2026
Brand
B BRAUN MEDICAL
Classification
Class II
Units affected
24,928 bags
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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.

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 # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.
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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