Sterile Water for Irrigation recall — Class II (D-0296-2026) · pharmaranks
Class IIOngoing
Sterile Water for Irrigation recall
FDA recall D-0296-2026 · initiated Dec 22, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Details
Product
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Recalling company
Baxter Healthcare Corporation
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide
Initiated
Dec 22, 2025
FDA report date
Feb 4, 2026
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.