Baxter Healthcare Corporation: Medical Device Recall in 2025 - (Recall #: Z-2096-2025)

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 V8, Model Number 35700BAX2

Product Classification:

Class I

Date Initiated: June 20, 2025

Date Posted: July 23, 2025

Recall Number: Z-2096-2025

Event ID: 97072

Reason for Recall:

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

Status: Ongoing

Product Quantity: 28 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated