BD Alaris Pump Module Model — Class I medical device recall Z-2179-2025
Ongoing recall by CareFusion 303, Inc., reported 2025-08-13, distributed nationwide. Infusion pump module used with compatible pump infusion sets may perform outside the established performance r
| Recall number | Z-2179-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2025-07-08 |
| Classified | 2025-08-06 |
| Reported by FDA | 2025-08-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, IT, JP, TR |
| Quantity | 33,162,680 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046 |
| Model numbers | 8100 |
Product
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Reason for recall
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
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-2179-2025. 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.