Agency classClass IOur severity:Severe FDA (Devices)·Z-1254-2025·Announced 2025-03-12

Baxter Spectrum IQ Infusion System may have missing motor mounting screws

Baxter Spectrum IQ Infusion Systems may lack motor mounting screws due to a servicing defect. The FDA Class I recall affects 323 units distributed nationwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall classification requires a minimum severity score of 4 per the severity rubric, regardless of reported injuries.

Plain-English summary

Baxter Healthcare Corporation is recalling 323 units of the Baxter Spectrum IQ Infusion System with Dose IQ Safety Software nationwide due to an FDA Class I recall.

Motor mounting screws may be missing from affected units, a defect that may have occurred during the servicing process.

The recall affects 323 units of the infusion system distributed throughout the United States. Specific serial numbers and UDI information are available from the FDA for identification of affected devices.

Healthcare facilities and practitioners using affected units should discontinue use and contact Baxter Healthcare Corporation for replacement guidance or further instructions.

The recalled product

Product: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Infusion System
Hazard: missing-components
mechanical-defect
Affected units: 323

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 (20)

UDI/DI 00085412610900
Serial Numbers: 3020290
3020992
3020996
3021929
3023080
3023183
3023537
3023758
3500529
3502799
3502864
3510806
3511639
3512647
3514801
3516888
3517399
3517517
3518558

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · missing components