Baxter Healthcare Corporation: Medical Device Recall in 2025 - (Recall #: Z-0776-2025)

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 with Master Drug Library (Version 8), Product Code 35700BAX2

Product Classification:

Class II

Date Initiated: November 19, 2024

Date Posted: January 8, 2025

Recall Number: Z-0776-2025

Event ID: 95848

Reason for Recall:

Devices were identified as released after repair without full testing being performed, which includes flow testing.

Status: Ongoing

Product Quantity: 1 unit

Code Information:

GTIN 00085412498683; Serial Number: 2153638

Distribution Pattern:

US Nationwide distribution in the states of AL, IN.

Voluntary or Mandated:

Voluntary: Firm initiated