FDA Device recall Z-1207-2025
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 t…
- FDA Device
- Class II
- ongoing
- Published 2025-03-05
On 2025-03-05 the FDA classified a Class II recall of 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 t… by Carefusion 303, citing due to fingerprint scanner failing resulting in the scanner heating up.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1207-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-23 |
| Published | 2025-03-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Carefusion 303 |
| Distribution | US |
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
Due to fingerprint scanner failing resulting in the scanner heating up.
Identifiers
| code_info | BD Pyxis MedFlex 2.0 Catalog Number: 1139-00 UDI-DI code: 10885403512704 Serial/Lot Numbers: 16188677 16234871 16234918…BD Pyxis MedFlex 2.0 Catalog Number: 1139-00 UDI-DI code: 10885403512704 Serial/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 16249394 16249395 16253258 16253259 16253260 16253261 16253264 16253421 16253423 16255087 16255088 16255089 16255090 16255091 16255092 16255093 16255094 16255648 16255649 16255650 16255651 16255652 16257751 16257779 16257780 16257782 16257783 16257784 16258336 16258339 16258341 16259235 16262553 16263864 16263866 16271070 16271697 16273523 16273525 16274621 16274623 16285712 16285719 16290130 16290131 16294039 16294040 16297183 16297187 16301869 16301974 16306024 16314884 16319674 16323805 16323807 16324856 16324858 16324880 16324881 1632488 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1207-2025%22
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