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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

B. Braun Sodium Chloride Irrigation Recalled for Particulate Matter

Agency Publication Date: April 8, 2025
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Summary

B. Braun Medical Inc has voluntarily recalled 32,256 bottles of 0.9% Sodium Chloride Irrigation USP, Isotonic Solution for Irrigation, packaged in 500 mL Plastic Irrigation Containers. This recall was initiated because particulate matter was discovered in the solution. If you are in possession of this product, you should immediately stop using it and contact the manufacturer or your distributor.

Risk

The presence of particulate matter in a solution intended for medical irrigation can lead to serious health complications, including inflammation or infection, if it enters the body during a procedure. No injuries or adverse events have been reported to date.

What You Should Do

  1. This recall affects 500 mL bottles of B. Braun 0.9% Sodium Chloride Irrigation USP, Isotonic Solution for Irrigation, with NDC 0264-2201-10.
  2. Check the product label for Lot # J4K936 and an expiration date of 7/31/2027 to determine if your supply is included in this recall.
  3. Stop using the recalled product immediately and contact B. Braun Medical Inc or your distributor to arrange for a return of the affected stock.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report a concern.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: 0.9% Sodium Chloride Irrigation USP, Isotonic Solution for Irrigation
Variants: 500 mL Plastic Irrigation Container (PIC)
Lot Numbers:
J4K936 (Exp 7/31/2027)
NDC:
0264-2201-10

Recall #: D-0353-2025; Manufactured by B. Braun Medical, Inc. in Bethlehem, PA.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96605
Status: Active
Manufacturer: B. Braun Medical Inc
Sold By: Distributors
Manufactured In: United States
Units Affected: 32,256 Bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.