BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD… — Class II medical device recall Z-1217-2026
Ongoing recall by CareFusion 303, Inc., reported 2026-02-04, distributed nationwide. Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjust
| Recall number | Z-1217-2026 |
|---|---|
| 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 | 2025-11-06 |
| Classified | 2026-01-29 |
| Reported by FDA | 2026-02-04 |
| Distributed | Nationwide (US) |
| Quantity | 189 devices |
| UPC / GTIN / UDI-DI | 10885403810046 |
| Serial numbers | 17377484, 17377907, 17377935, 17377939, 17377942, 17377946, 17377948, 17377952, 17377959, 17377961, 17377965, 17377970, 17377972, 17377973, 17377976, 17377978, 17377980, 17377987, 17377992, 17377993, 17378071, 17378072, 17378073, 17378074, 17378075 and 164 more |
| Model numbers | 8100 |
Product
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.
Reason for recall
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
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-1217-2026. 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.