Baxter Healthcare Corporation recalls Sterile Water for Irrigation
- Recalling company
- Baxter Healthcare Corporation
- Product
- Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
- Reason
- Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 22, 2025
- Reported
- Feb 4, 2026
- Distribution
- Nationwide
- Status
- Ongoing
- Quantity
- 125,496 bottles
- Lot / codes
- Lot #: G171359, expiry: 05/31/2027
- Company location
- Deerfield, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0296-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0296-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.