(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia… — Class II medical device recall Z-1120-2025
Ongoing recall by CareFusion 303, Inc., reported 2025-02-19, distributed nationwide. Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an a
| Recall number | Z-1120-2025 |
|---|---|
| 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 | 193,067 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10885403477829, 10885403477836, 10885403512629, 10885403512636, 10885403512667, 10885403512674, 10885403513787 |
| Model numbers | 303, 309, 323, 327, 338, 352 |
Product
(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338
Reason for recall
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
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-1120-2025. 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.