Reported Apr 29, 2026 · Ongoing
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524,…
B Braun Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B BRAUN MEDICAL INC · 861 Marcon Blvd · Allentown, PA · 18109-9577
Is this the product you have?
- 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA
- NDC0264-7388-60
- Lot codes and dates
Lot # J5E226J5E227J5E228J5E229J5E230J5E231J5E232J5E233J5E238J5E239
- Exp Date
30Apr2028Lot # J5E240J5E241J5E242J5E243J5E244J5E245J5E247J5E248
- Exp Date
30Apr2028Lot # J5H151J5H152J5H153J5H154J5H155
- Exp Date31 May2028
- Amount recalled
- 124,244 bags
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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