Sterile Water for Irrigation — Class II drug recall D-0296-2026
Ongoing recall by Baxter Healthcare Corporation, reported 2026-02-04, distributed nationwide. Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
| Recall number | D-0296-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2025-12-22 |
| Classified | 2026-01-23 |
| Reported by FDA | 2026-02-04 |
| Distributed | Nationwide (US) |
| Quantity | 125,496 bottles |
| Reason classes | specification failure |
| NDC | 00338-0003, 00338-0003-44, 00338-0003-46, 00338-0003-47, 00338-0004, 00338-0004-02, 00338-0004-03, 00338-0004-04, 00338-0004-05 |
| Lot numbers | G171359 |
| Expiration dates | 2027-05-31 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0296-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.