BD Pyxis: MedFlex — Class II medical device recall Z-1206-2025
Ongoing recall by CareFusion 303, Inc., reported 2025-03-05, distributed nationwide. Automated dispensing device labeling is being updated to strengthen labeling around manual access to medicatio
| Recall number | Z-1206-2025 |
|---|---|
| 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 | 2025-01-10 |
| Classified | 2025-02-21 |
| Reported by FDA | 2025-03-05 |
| Distributed | Nationwide (US) |
| Quantity | 1,521 |
| Reason classes | labeling, device malfunction |
| UPC / GTIN / UDI-DI | 10885403512704, 10885403517167 |
| Serial numbers | 13523350, 13754724, 13767953, 13789575, 13801727, 13826187, 13879544, 13883357, 13884848, 139088-01/43847406, 13934472, 13939327, 13948724, 14032802, 14037891, 14158187, 14159916, 14168580, 14172832, 14175162, 14182716, 14202337, 14220872, 14222746, 14228149 and 475 more |
| Model numbers | 1119-00, 1145-00, 139088-01, 155018-03 |
Product
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
Reason for recall
Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.
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-1206-2025. 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.