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Drug FDA Class II Ongoing Contamination / non-sterility

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.

B BRAUN MEDICAL INC Published Apr 29, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact B BRAUN MEDICAL INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Lack of Assurance of Sterility · primary

Affected products (1)

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.

SODIUM CHLORIDE FOR IRRIGATION · 124,244 bags

NDC: 0264-7388, 0264-7388-50, 0264-7388-60
Lot codes: J5E226, J5E240, J5H151
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.

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 2, 2026
  2. Published
    Apr 29, 2026
Recall number
D-0497-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.