Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SIGMA Spectrum Infusion Pump Recalled by Baxter Healthcare Corporation Due to Certain pumps have potentially been released from service...

Date: November 28, 2025
Company: Baxter Healthcare Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Baxter Healthcare Corporation directly.

Affected Products

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

Quantity: 585 units

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Baxter Healthcare Corporation

Baxter Healthcare Corporation has 401 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report