Warning
Baxter Healthcare Corporation Recalls Sterile Water for Irrigation
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0296-2026Drug / Pharmaceutical
Baxter Healthcare Corporation Recalls Sterile Water for Irrigation
Baxter Healthcare Corporation · Class II — Moderate Risk
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
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Baxter Healthcare Corporation initiated the recall on December 22, 2025 affecting 125,496 bottles. Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution. The product was distributed nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Baxter Healthcare Corporation for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.