Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Pending LLM rewrite. Source: FDA_DEVICE Z-2096-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Certain Spectrum infusion pumps may have an incorrect version of software.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 00085412498683
- Serial Numbers: 2006307
- 2052091
- 2093765
- 2095360
- 2104302
- 2119236
- 2141815
- 2025925
- 2067699
- 2094483
- 2095541
- 2105238
- 2119436
- 2143406
- 2034297
- 2074097
- 2094580
- 2096351
- 2105769
Distribution
Distributed in 10 states:
- CA
- FL
- IL
- KS
- MI
- MS
- NY
- OH
- OK
- VA
Related recalls
Same category
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22