BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower — Class II medical device recall Z-1545-2025
Ongoing recall by CareFusion 303, Inc., reported 2025-04-16, distributed nationwide. Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the
| Recall number | Z-1545-2025 |
|---|---|
| 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 | 2025-03-11 |
| Classified | 2025-04-09 |
| Reported by FDA | 2025-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 7,357 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10885403503542, 10885403503559, 10885403503566, 10885403503573, 10885403503597, 10885403503603, 10885403503610, 10885403503658, 10885403503665, 10885403503672, 10885403503689, 10885403503696, 10885403503702, 10885403503719, 10885403503726, 10885403503733, 10885403503740, 10885403503757, 10885403503764, 10885403503771, 10885403503788, 10885403503795, 10885403503801, 10885403503818, 10885403503870 and 59 more |
Product
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings.
Reason for recall
Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.
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-1545-2025. 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.