Baxter Healthcare Corporation: Device Recall

Recall #Z-0776-2025 · 11/19/2024

Class II: Risk

Recall Details

Recall Number: Z-0776-2025
Classification: Class II
Product Type: Device
Recalling Firm: Baxter Healthcare Corporation
Status: Ongoing
Date Initiated: 11/19/2024
Location: Deerfield, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1 unit

Reason for Recall

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

Product Description

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2

Distribution Pattern

US Nationwide distribution in the states of AL, IN.

Other Recalls by Baxter Healthcare Corporation

Class II: Risk 12/22/2025

Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Class II: Risk 11/28/2025

Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
Class II: Risk 10/28/2025

Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
Class II: Risk 09/17/2025

Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
Class II: Risk 08/29/2025

IV sets may leak.

View all recalls by Baxter Healthcare Corporation →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.