FDAFDA · Food and drugs·Recall number D-0296-2026
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Published February 4, 2026 · Recall initiated: December 22, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- STERILE WATER
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Nationwide
- Lot
- Lot #: G171359, expiry: 05/31/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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