Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-2581-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump

Product Classification:

Class II

Date Initiated: July 17, 2024

Date Posted: August 28, 2024

Recall Number: Z-2581-2024

Event ID: 94988

Reason for Recall:

The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.

Status: Ongoing

Product Quantity: 17,377 units

Code Information:

Pump GTIN 00085412498683; All serial numbers with radio software versions 22D28, 22D29, and 22D30

Distribution Pattern:

US, Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated