FDAClass II · Drug · Recalled April 29, 2026

LACTATED RINGER'S IRRIGATION 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-0498-2026
Brand: B BRAUN MEDICAL
Classification: Class II
Units affected: 54,540 bags
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.

Affected products

LACTATED RINGER'S IRRIGATION

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 # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.
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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