Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle

Baxter Healthcare Corporation has recalled Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on February 4, 2026 and was initiated on December 22, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, with approximately 125,496 bottles affected. The company behind the recall is Baxter Healthcare Corporation, based in Deerfield, IL. The FDA describes the product as: “Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.”

Why was Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle recalled?

According to the FDA, the stated reason for the recall is: “Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution.” In plain terms, this recall relates to foreign material.

A foreign material recall means that pieces of something which should not be in food — such as metal, plastic, or glass — may be present. These can pose a choking hazard or cause injury. Recalls like these are issued to remove the affected product before anyone is hurt.

What should you do?

If you think you may have bought Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, compare it against the product description and identifying codes (Lot #: G171359, expiry: 05/31/2027) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Baxter Healthcare Corporation or your local health authority.

About this recall

This recall was distributed in IL. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.