← FDA ENFORCEMENT
D-0498-2026Class II

B BRAUN MEDICAL INC

Recalling firm
B BRAUN MEDICAL INC
Product type
Drug
Status
Ongoing
Report date
2026-04-29
Distribution
US Nationwide.
Firm state
PA
Product quantity
54,540 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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

Code / lot info

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

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See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.