BD Pyxis: MedStation ES — Class II medical device recall Z-2374-2024
Ongoing recall by CareFusion 303, Inc., reported 2024-07-24, distributed nationwide. If automated dispensing cabinets have specific software versions, and Component Manager was configured to "ins
| Recall number | Z-2374-2024 |
|---|---|
| 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 | 2024-05-02 |
| Classified | 2024-07-17 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Quantity | 326 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10885403477836, 10885403512605, 10885403512667, 10885403512674 |
| Serial numbers | 12345678, 13347728, 13534745, 13781497, 13839287, 13839299, 13841400, 13877154, 14019332, 14138516, 14157588, 14232856, 14442210, 14557551, 14572826, 14613489, 14668921, 14697245, 14700155, 14728645, 14806556, 14813899, 14826153, 14826969, 14826971 and 294 more |
| Model numbers | 107-254-01, 107-255-01, 107-256-01, 107-257-01, 1116-00, 323, 327, 352 |
Product
BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01
Reason for recall
If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing 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-2374-2024. 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.