The Recall Desk
Severity pendingFDA (Devices)·Z-2095-2025·Announced 2025-07-23

Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

Pending LLM rewrite. Source: FDA_DEVICE Z-2095-2025.

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 V6, Model Number 35700BAX
Manufacturer
Baxter Healthcare Corporation

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 (13)

  • UDI-DI: 00085412091570
  • Serial Numbers: 765100
  • 772744
  • 789742
  • 841197
  • 867753
  • 920606
  • 1024015 770164 788724
  • 793079
  • 842498
  • 918342
  • 962810
  • 1027523

Distribution

Distributed in 10 states:

  • CA
  • FL
  • IL
  • KS
  • MI
  • MS
  • NY
  • OH
  • OK
  • VA