Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

© 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

B. Braun Sterile Water and Saline Irrigation Bags Recalled for Leakage

Agency Publication Date: September 16, 2025
Share:
Sign in to monitor this recall

Summary

B. Braun Medical Inc. is recalling 42,544 units of Sterile Water for Injection and 0.9% Sodium Chloride Irrigation solution in 3,000 mL bags because the ports may be misaligned. This defect can cause fluid to leak from the bag, which compromises the sterility of the medical fluid. These products are prescription-only liquids used in clinical settings for irrigation and injection.

Risk

A misaligned port can lead to fluid leakage and a lack of assurance that the solution remains sterile. Using a non-sterile medical fluid can lead to serious infections or other health complications for patients.

What You Should Do

  1. Identify if you have the recalled 3,000 mL bags of Sterile Water for Injection (NDC 0264-7385-60) or 0.9% Sodium Chloride Irrigation (NDC 0264-7388-60) by checking the lot numbers and expiration dates on the packaging.
  2. For Sterile Water, check for lot numbers J3L519, J3L528 (Exp. 31AUG2026), J4C522, or J4C523 (Exp. 28FEB2027).
  3. For Sodium Chloride Irrigation, check for lot numbers J4C521, J4C516, or J4C524 (Exp. 28FEB2027).
  4. Stop using the recalled product immediately.
  5. Contact B. Braun Medical Inc. or your distributor to arrange for the return of any remaining affected stock.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Your Remedy Options

📋Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: STERILE WATER FOR INJECTION USP (3000mL)
Variants: Rx only
Lot Numbers:
J3L519 (Exp.: 31AUG2026)
J3L528 (Exp.: 31AUG2026)
J4C522 (Exp.: 28FEB2027)
J4C523 (Exp.: 28FEB2027)
NDC:
0264-7385-60

Recall #: D-0652-2025; Quantity: 26,316 bags.

Product: 0.9% SODIUM CHLORIDE IRRIGATION USP, ISOTONIC SOLUTION FOR IRRIGATION (3000mL)
Variants: Rx only
Lot Numbers:
J4C521 (Exp. : 28FEB2027)
J4C516 (Exp. : 28FEB2027)
J4C524 (Exp. : 28FEB2027)
NDC:
0264-7388-60

Recall #: D-0653-2025; Quantity: 16,228 bags.

Product Images

1: 0.9% Sodium Chloride Injection USP 1000 mL

1: 0.9% Sodium Chloride Injection USP 1000 mL

Lactated Ringer’s Injection USP 1000 mL

Lactated Ringer’s Injection USP 1000 mL

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97477
Status: Active
Manufacturer: B BRAUN MEDICAL INC
Sold By: Direct distribution; Wholesalers; Hospitals
Manufactured In: United States
Units Affected: 2 products (26,316 3000 mL bags; 16,228 3000 mL bags)
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 · FDA Press Release · 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.