BD Pyxis CII Safe — Class II medical device recall Z-2094-2023
Ongoing recall by CareFusion 303, Inc., reported 2023-07-12, distributed nationwide. Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptabl
| Recall number | Z-2094-2023 |
|---|---|
| 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 | 2023-05-22 |
| Classified | 2023-07-05 |
| Reported by FDA | 2023-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 9,906 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10885403512520 |
| Model numbers | 107-223, 107-224, 107-252-01, 107-254-01, 107-255-01, 107-96, 107-97, 107-97-201, 111-113, 111-114, 111-115, 111-160-201, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198, 111-215, 111-216, 111-217, 111-218, 111-219 and 6 more |
Product
BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01, 111-203-01, 111-204-01, 111-205-01, 111-206-01, 107-245-01, 107-246-01; BD Pyxis CII Safe, Software: V9, REF: 107-252-01, 111-215, 111-216, 111-219, 111-221. BD Pyxis CII Safe, Software: ES, REF: 107-254-01, 107-255-01, 1116-00, 1117-00; BD Pyxis CII Safe, Software: N/A, REF: 111-113, 111-114, 111-115, 111-160-201, 111-217, 111-218, 111-220, 111-222; Tripp Lite SUPER6TEL Surge Suppressor, REF: CN 200-025. Used with BD Pyxis CII Safe System: v7.x for WES7 User Guide, DIR 10000145747/ v8.1 User Guide, DIR 10000277635/v9.0 User Guide, DIR 10000354270/ ES User Guide v1.8, DIR 10000418517
Reason for recall
Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose users to system downtime and/or potential electric shock.
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-2094-2023. 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.