Baxter Healthcare Corporation recalls SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

Recall date

November 28, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1121-2026

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

US Nationwide distribution.

Why it was recalled

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 means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2