FDA·Healthcare and labs·February 4, 2026

Baxter recalls Sterile Water for Irrigation 250 mL bottles over plastic particles in the liquid

Plastic particles from the bottle rim were seen floating in the sterile water, so the liquid may be contaminated with small bits of plastic.

What to do

The notice does not give instructions. Read the official notice for details.

Recall details

Product
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Hazard
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Units
125,496 bottles
Where sold
Nationwide
FDA classification
Class II · Ongoing
Classified by FDA
January 23, 2026
Recall started
December 22, 2025
FDA enforcement report
February 4, 2026
Identifiers
  • Codes: Lot #: G171359, expiry: 05/31/2027
  • FDA recall number: D-0296-2026

The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.

Official notice

The notice's own wording from FDA.

Product
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Reason for recall
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Classification
Class II (Ongoing)
Distribution
Nationwide
Quantity
125,496 bottles

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