BD Pyxis MedFlex 2 — Class II medical device recall Z-1207-2025
Ongoing recall by CareFusion 303, Inc., reported 2025-03-05, distributed nationwide. Due to fingerprint scanner failing resulting in the scanner heating up.
| Recall number | Z-1207-2025 |
|---|---|
| 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 | 2025-01-23 |
| Classified | 2025-02-21 |
| Reported by FDA | 2025-03-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BH, BR, CA, ES, HK, KW, LB, NZ, QA, SA, TH |
| UPC / GTIN / UDI-DI | 10885403450136, 10885403512704 |
| Lot numbers | 16188677, 16234871, 16234918, 16234919, 16234920, 16235771, 16235773, 16235774, 16235776, 16235777, 16235778, 16235779, 16235780, 16237465, 16237466, 16237807, 16237809, 16237810, 16237811, 16237812, 16237813, 16238647, 16245711, 16245712, 16245713, 16245718, 16248197, 16248200, 16248203, 16248207, 16248208, 16248209, 16248211, 16248214, 16248216, 16248217, 16249389, 16249390, 16249392, 16249393 and 189 more |
| Model numbers | 1139-00, 353200-01 |
Product
BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies to a qualified and authorized user in a clinical setting.
Reason for recall
Due to fingerprint scanner failing resulting in the scanner heating up.
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-1207-2025. 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.