FDA Drug recall D-0296-2026
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004…
- FDA Drug
- Class II
- ongoing
- Published 2026-02-04
On 2026-02-04 the FDA classified a Class II recall of Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004… by Baxter Healthcare, citing presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0296-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-22 |
| Published | 2026-02-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Reason
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Identifiers
| ndc | 0338-0003-44 |
|---|---|
| ndc | 0338-0003-46 |
| ndc | 0338-0003-47 |
| ndc | 0338-0004-02 |
| ndc | 0338-0004-03 |
| ndc | 0338-0004-04 |
| ndc | 0338-0004-05 |
| code_info | Lot #: G171359, expiry: 05/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0296-2026%22
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