BD Pyxis ES Enterprise Server Catalog Numbers 1115-00 — Class II medical device recall Z-1028-2026
Ongoing recall by CareFusion 303, Inc., reported 2026-01-14, distributed nationwide. Due a software issue that may result in equipment not receiving timely updates of patient, medication, or rela
| Recall number | Z-1028-2026 |
|---|---|
| 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 | 2025-12-03 |
| Classified | 2026-01-08 |
| Reported by FDA | 2026-01-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, CA |
| Quantity | 2,079 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10885403518348, 10885403520341 |
| Model numbers | 1115-00, 133744-01, 133760-01, 134148-01, 134149-01, 134157-01, 136448-01, 136448-02, 136449-01, 136449-02, 136450-01, 136450-02, 136451-01, 136451-02, 136452-01, 136452-02, 137081-01, 137669-02, 137669-03, 137670-02, 137670-03, 137671-02, 137671-03, 137672-02, 137672-03 and 14 more |
Product
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01 Software Versions: System Versions 1.6.1 - 1.11.0 Server Application Versions ES 5.4X - 5.8.X The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products.
Reason for recall
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
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-1028-2026. 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.