⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

B BRAUN MEDICAL INC: 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-

DrugsSource: FDA (drug) · Date: 2026-04-29

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
B BRAUN MEDICAL INC
Product
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
Reason / hazard
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide.
Recall initiated
2026-04-02
Code info
Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028.
Product quantity
124,244 bags
Voluntary mandated
Voluntary: Firm initiated
City
Allentown
State
PA
Country
United States
Event id
98693
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