FDA Recall D-0296-2026
Baxter Healthcare Corporation · Deerfield, IL
Class II Ongoing 143 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0296-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2025-12-22
- Classified by FDA Center
- 2026-01-23
- FDA published
- 2026-02-04
- Recalling firm
- Baxter Healthcare Corporation
- Firm location
- Deerfield, IL
Drug identification
- Brand name(s)
- STERILE WATER
- Generic name(s)
- WATER
- Manufacturer(s)
- Baxter Healthcare Corporation
- NDC(s)
0338-0003, 0338-0004- Route(s)
- IRRIGATION
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.