(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia… — Class II medical device recall Z-1119-2025
Ongoing recall by CareFusion 303, Inc., reported 2025-02-19, distributed nationwide. Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong
| Recall number | Z-1119-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2025-01-08 |
| Classified | 2025-02-07 |
| Reported by FDA | 2025-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 137,741 total |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10885403477836, 10885403512605, 10885403512667, 10885403512674 |
| Model numbers | 1116-00, 323, 327, 352 |
Product
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
Reason for recall
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
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/Z-1119-2025. 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.