BD Pyxis MedStation ES — Class II medical device recall Z-0962-2026
Ongoing recall by CareFusion 303, Inc., reported 2025-12-31, distributed nationwide. Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie
| Recall number | Z-0962-2026 |
|---|---|
| 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 | 2025-11-20 |
| Classified | 2025-12-19 |
| Reported by FDA | 2025-12-31 |
| Distributed | Nationwide (US) |
| Quantity | 53,669 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10885403512605, 10885403512667, 10885403512674, 10885403512681, 10885403517822, 10885403517839, 10885403521300 |
| Model numbers | 1116-00, 1149-00, 1152-00, 1155-00, 323, 324, 352 |
Product
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main, REF: 1155-00, BD Pyxis CII Safe ES, REF: 1116-00
Reason for recall
Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.
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-0962-2026. 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.