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Home › FDA recalls › LACTATED RINGER'S IRRIGATION
CLASS II · ModerateFDA

B BRAUN MEDICAL INC recalls LACTATED RINGER'S IRRIGATION

📅 Apr 2, 2026 · 📍 Nationwide
Recalling company
B BRAUN MEDICAL INC
Product
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
Reason
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Apr 2, 2026
Reported
Apr 29, 2026
Distribution
US Nationwide.
Status
Ongoing
Quantity
54,540 bags
Lot / codes
Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.
Company location
Allentown, PA
Recall type
Voluntary: Firm initiated
Recall number
D-0498-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0498-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.