Agency classClass IIOur severity:High FDA (Devices)·Z-2415-2025·Announced 2025-09-03

Infusion pumps recalled because degrading grease may cause excessive therapy delivery

Six Baxter Spectrum IQ Infusion Pumps are recalled because grease applied to the cam and motor gears may break down, causing premature wear and potentially excessive therapy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice states the defect could result in excessive therapy being delivered and reports no injuries.

Plain-English summary

The Spectrum IQ Infusion Pump, product code 3570009, UDI-DI 00085412610900, is being recalled for serial numbers 3815255, 3815261, 3815265, 3815266, 3815267 and 3815271. The recall covers 6 units distributed in Arizona and Florida.

Baxter identified that certain pumps may have been released with grease applied to the cam and motor gears that will break down quickly. The breakdown leads to insufficient or ineffective grease on the cam, which could cause premature wear of the mechanism assembly and result in excessive therapy. The FDA classified the action as Class II.

Hospitals holding these serial numbers should remove the affected pumps from service and follow Baxter's instructions for return or replacement.

The recalled product

Product: Spectrum IQ Infusion Pump, Product Code 3570009
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Infusion Pump
Hazard: over-infusion
mechanical-wear
infusion-pump
class-ii
Affected units: 6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

UDI-DI: 00085412610900
Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271

Distribution

Distributed in 2 states:

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · over infusion