Drug FDA Class II Ongoing Foreign material

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

Baxter Healthcare Corporation Published Feb 4, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Baxter Healthcare Corporation or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution

Hazards

Plastic Particles · primary

Affected products (1)

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

STERILE WATER · 125,496 bottles

NDC: 0338-0003, 0338-0004, 0338-0003-44, 0338-0003-46, 0338-0003-47, 0338-0004-02, 0338-0004-03, 0338-0004-04, 0338-0004-05

Code info: Lot #: G171359, expiry: 05/31/2027

Affected areas

Nationwide

Timeline

Initiated

Dec 22, 2025
Published

Feb 4, 2026

Recall number: D-0296-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.