FDAClass IIFebruary 4, 2026

Sterile Water for Irrigation recall: Particulate Matter

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 recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Recalling firm
Baxter Healthcare Corporation
Quantity
125,496 bottles
Distribution
Nationwide
Recall date
February 4, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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