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Class II · ModerateActive recall

Sodium Chloride For Irrigation

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # 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.
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byB. Braun Medical Inc.
Brand nameSODIUM CHLORIDE FOR IRRIGATION
Generic nameSODIUM CHLORIDE FOR IRRIGATION
Active ingredient(s)SODIUM CHLORIDE
Distributed by / forB BRAUN MEDICAL INC
NDC0264-7388-60
Show the full FDA record
Full product label0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
Recalling firmB BRAUN MEDICAL INC
DistributionUS Nationwide.
Quantity124,244 bags
Recall initiated2026-04-02
Report date2026-04-29
Recall completed—
Recall numberD-0497-2026
ClassificationClass II
FDA statusOngoing
Origin on fileAllentown PA United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.