FDA recall D-0296-2026

Baxter Healthcare Corporation · Class II · drug

Product

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.

Reason for recall

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

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2025-12-22
Report date
2026-02-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0296-2026