Baxter Healthcare Corporation: Medical Device Recall in 2025 - (Recall #: Z-2095-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

Product Classification:

Class I

Date Initiated: June 20, 2025

Date Posted: July 23, 2025

Recall Number: Z-2095-2025

Event ID: 97072

Reason for Recall:

Certain Spectrum infusion pumps may have an incorrect version of software.

Status: Ongoing

Product Quantity: 14 units

Code Information:

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

Distribution Pattern:

US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated