Baxter Spectrum IQ Infusion System with Dose IQ Safety Software — Class II medical device recall Z-0348-2025
Ongoing recall by Baxter Healthcare Corporation, reported 2024-11-20, distributed in GA, ID. The door on the Spectrum IQ Infusion pump may not be able to fully close.
| Recall number | Z-0348-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-10-02 |
| Classified | 2024-11-08 |
| Reported by FDA | 2024-11-20 |
| Distributed | GA, ID |
| Quantity | 8 units |
| UPC / GTIN / UDI-DI | 00085412610900 |
| Serial numbers | 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, 3798200 |
Product
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Reason for recall
The door on the Spectrum IQ Infusion pump may not be able to fully close.
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-0348-2025. 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.