PlainRecalls
FDA Drug Moderate Class II Ongoing

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.

Reported: February 4, 2026 Initiated: December 22, 2025 #D-0296-2026

Product Description

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

Details

Units Affected
125,496 bottles
Distribution
Nationwide
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.. Recalled by Baxter Healthcare Corporation. Units affected: 125,496 bottles.
Why was this product recalled?
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Which agency issued this recall?
This recall was issued by the FDA Drug on February 4, 2026. Severity: Moderate. Recall number: D-0296-2026.