All Serial Numbers/BD Pyxis CII Safe ES Tower Main — Class II medical device recall Z-0371-2026
Ongoing recall by CareFusion 303, Inc., reported 2025-11-05, distributed nationwide. Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
| Recall number | Z-0371-2026 |
|---|---|
| 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 | 2025-09-30 |
| Classified | 2025-10-27 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA |
| Quantity | 443 units |
| UPC / GTIN / UDI-DI | 10885403512605 |
| Model numbers | 1116-00 |
Product
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
Reason for recall
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
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-0371-2026. 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.