Baxter Sigma Spectrum Infusion System — Class I medical device recall Z-1253-2025
Ongoing recall by Baxter Healthcare Corporation, reported 2025-03-12, distributed nationwide. There is the potential for missing motor mounting screws, which may have occurred during the servicing process
| Recall number | Z-1253-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2025-02-05 |
| Classified | 2025-03-06 |
| Reported by FDA | 2025-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 66 units |
| UPC / GTIN / UDI-DI | 00085412091570 |
| Serial numbers | 1006359, 1011058, 1013925, 1014064, 1014529, 1014856, 1017150, 1017546, 1018229, 1018703, 1024109, 704198, 728888, 751492, 758399, 758614, 761662, 763197, 766291, 772611, 773302, 775486, 778837, 785425, 793453 and 41 more |
Product
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
Reason for recall
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
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-1253-2025. 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.