FDA Device recall Z-2095-2025
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
- 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 V6, Model Number 35700BAX 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-2095-2025 |
| 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 V6, Model Number 35700BAX
Reason
Certain Spectrum infusion pumps may have an incorrect version of software.
Identifiers
| code_info | UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 7…UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523 |
|---|
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-2095-2025%22
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