⚠ 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
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
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 23, 2026 at 11:04 PM UTC.
Report a data error on this page