Recall Z-2415-2025— Baxter Healthcare Corporation

Name: FDA recall Z-2415-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-14

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-07-14. It names one FDA 510(k) clearance: K230041. Product: Spectrum IQ Infusion Pump, Product Code 3570009. Reason: Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-07-14
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K230041 — Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation·cleared 2023-03-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Spectrum IQ Infusion Pump, Product Code 3570009

Reason for recall

Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.

Data sourced from openFDA. This site is unofficial and independent of the FDA.