FDA Device recall Z-2096-2025
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
- FDA Device
- Class I
- ongoing
- Published 2025-07-23
On 2025-07-23 the FDA classified a Class I recall of Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 by Baxter Healthcare, citing certain Spectrum infusion pumps may have an incorrect version of software.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2096-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-06-20 |
| Published | 2025-07-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | CA, FL, IL, KS, MI, MS, NY, OH, OK, VA |
Product
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Reason
Certain Spectrum infusion pumps may have an incorrect version of software.
Identifiers
| code_info | UDI-DI: 00085412498683; Serial Numbers: 2006307 , 2052091 , 2093765 , 2095360 , 2104302 , 2119236 , 2141815 , 2025925 ,…UDI-DI: 00085412498683; Serial Numbers: 2006307 , 2052091 , 2093765 , 2095360 , 2104302 , 2119236 , 2141815 , 2025925 , 2067699 , 2094483 , 2095541 , 2105238 , 2119436 , 2143406 , 2034297 , 2074097 , 2094580 , 2096351 , 2105769 , 2135482 , 2143684 , 2051591 , 2090658 , 2095202 , 2096856 , 2118940 , 2137976 , 2156201 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2096-2025%22
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