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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

B. Braun Sterile Water and Irrigation Bags Recalled for Sterility Risks

Agency Publication Date: April 22, 2026
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Summary

B. Braun Medical Inc. is recalling approximately 220,836 bags of various sterile fluids, including Sterile Water for Injection, Dextrose Injection, Sodium Chloride Irrigation, and Lactated Ringer's Irrigation. The recall was initiated because the diaphragm port on the bags may leak once the protective foil is removed. This defect creates a lack of assurance of sterility, which can lead to serious infections in patients receiving these fluids.

Risk

A leak in the bag's port can allow bacteria or other contaminants to enter the fluid, potentially causing life-threatening bloodstream or tissue infections in patients.

What You Should Do

  1. Stop using the recalled products immediately.
  2. Identify affected products by checking for NDC numbers 0264-7385-60, 0264-7387-50, 0264-7388-60, or 0264-7389-60 and their associated lot numbers.
  3. Check for lot numbers J5H165, J5E237, J5H166, J5H167, J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, J5H151, J5H152, J5H153, J5H154, J5H155, J5E234, J5E236, J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, or J5H175. See the Affected Products section below for the full list of affected codes.
  4. Contact the manufacturer or your distributor to arrange for the return of any unused product.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Sterile Water for Injection USP (3000 mL)
Variants: Pharmacy Bulk Package, Rx only
Lot Numbers:
J5H165 (Exp 31 May2028)
J5E237 (Exp 30APR2028)
NDC:
0264-7385-60

Recall #: D-0495-2026; Quantity: 24,928 bags

Product: DEXTROSE INJECTION USP, 70% (2000 mL)
Variants: Sterile, Rx only
Lot Numbers:
J5H166 (Exp 30NOV2026)
J5H167 (Exp 30NOV2026)
NDC:
0264-7387-50

Recall #: D-0496-2026; Quantity: 17,124 bags

Product: 0.9 % SODIUM CHLORIDE IRRIGATION, USP (3000 mL)
Variants: Sterile, Rx only
Lot Numbers:
J5E226 (Exp 30Apr2028)
J5E227 (Exp 30Apr2028)
J5E228 (Exp 30Apr2028)
J5E229 (Exp 30Apr2028)
J5E230 (Exp 30Apr2028)
J5E231 (Exp 30Apr2028)
J5E232 (Exp 30Apr2028)
J5E233 (Exp 30Apr2028)
J5E238 (Exp 30Apr2028)
J5E239 (Exp 30Apr2028)
J5E240 (Exp 30Apr2028)
J5E241 (Exp 30Apr2028)
J5E242 (Exp 30Apr2028)
J5E243 (Exp 30Apr2028)
J5E244 (Exp 30Apr2028)
J5E245 (Exp 30Apr2028)
J5E247 (Exp 30Apr2028)
J5E248 (Exp 30Apr2028)
J5H151 (Exp 31 May2028)
J5H152 (Exp 31 May2028)
J5H153 (Exp 31 May2028)
J5H154 (Exp 31 May2028)
J5H155 (Exp 31 May2028)
NDC:
0264-7388-60

Recall #: D-0497-2026; Quantity: 124,244 bags

Product: LACTATED RINGER'S IRRIGATION (3000 mL)
Variants: Sterile, Rx only
Lot Numbers:
J5E234 (Exp 30APR2028)
J5E236 (Exp 30APR2028)
J5H158 (Exp 31MAY2028)
J5H159 (Exp 31MAY2028)
J5H160 (Exp 31MAY2028)
J5H161 (Exp 31MAY2028)
J5H162 (Exp 31MAY2028)
J5H163 (Exp 31MAY2028)
J5H174 (Exp 31MAY2028)
J5H175 (Exp 31MAY2028)
NDC:
0264-7389-60

Recall #: D-0498-2026; Quantity: 54,540 bags

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98693
Status: Active
Manufacturer: B BRAUN MEDICAL INC
Sold By: Hospitals; Surgical centers; Infusion centers
Manufactured In: United States
Units Affected: 4 products (24,928 bags; 17,124 bags; 124,244 bags; 54,540 bags)
Distributed To: Nationwide
Agency Last Updated: April 28, 2026

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.