Baxter SIGMA Spectrum Infusion Pump V6 — Class I medical device recall Z-2095-2025
Ongoing recall by Baxter Healthcare Corporation, reported 2025-07-23, distributed in CA, FL, IL, KS, MI, MS, NY, OH…. Certain Spectrum infusion pumps may have an incorrect version of software.
| Recall number | Z-2095-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2025-06-20 |
| Classified | 2025-07-17 |
| Reported by FDA | 2025-07-23 |
| Distributed | CA, FL, IL, KS, MI, MS, NY, OH, OK, VA |
| Quantity | 14 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00085412091570 |
| Serial numbers | 1024015, 1027523, 765100, 770164, 772744, 788724, 789742, 793079, 841197, 842498, 867753, 918342, 920606, 962810 |
| Model numbers | 35700BAX |
Product
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Reason for recall
Certain Spectrum infusion pumps may have an incorrect version of software.
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-2095-2025. 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.