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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sterile Water for Irrigation Recalled for Plastic Particulate Matter

Agency Publication Date: January 23, 2026
Share:
Sign in to monitor this recall

Summary

Baxter Healthcare Corporation is recalling approximately 125,496 bottles of Sterile Water for Irrigation (250 mL) because plastic particles from the bottle rim were found floating in the solution. This recall affects single-dose plastic bottles sold under NDC 0338-0004-02. This is a clinical product typically used in hospital or surgical settings, and healthcare providers are advised to stop using the affected lot immediately to avoid potential patient complications.

Risk

The presence of plastic particulate matter in a sterile solution can lead to serious health issues if the solution is used during medical procedures. If these particles enter a patient's body, they can cause local inflammation, tissue damage, or blockages in small blood vessels.

What You Should Do

  1. Check your inventory for Sterile Water for Irrigation, 250 mL Single-Dose Plastic Bottles with NDC 0338-0004-02 and Lot number G171359 (Expiration date: 05/31/2027).
  2. Stop using the recalled product immediately.
  3. Contact Baxter Healthcare Corporation or your medical distributor to arrange for the return of any unused product from the affected lot.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

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 Irrigation (250 mL)
Variants: Single-Dose Plastic Bottle, Rx Only
Lot Numbers:
G171359 (Exp 05/31/2027)
NDC:
0338-0004-02

Quantity: 125,496 bottles

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98178
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Hospitals; Medical distributors
Manufactured In: United States
Units Affected: 125,496 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.