Agency classClass IOur severity:Critical FDA (Devices)·Z-2333-2025·Announced 2025-09-10

Syringe pumps recalled over false motor movement system error messages

Baxter is issuing an urgent correction for Novum IQ Syringe Pumps, product code 40800BAXUS, over software anomalies causing a blank Run screen or a false motor movement system error. 10,101 units are affected.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The rubric assigns 5 to any FDA Class I action, and the FDA classified this infusion pump correction as Class I.

Plain-English summary

The Novum IQ Syringe Pump, product code 40800BAXUS, UDI/DI 05413765852428, is the subject of an Urgent Medical Device Correction covering all serial numbers. The recall covers 10,101 units distributed in the United States including Puerto Rico, and in Canada.

Baxter Healthcare Corporation issued the correction for the Novum IQ Large Volume Pump and Novum IQ Syringe Pump because of software anomalies that may result in a blank Run screen on both pump types, and a false motor movement system error on the syringe pump. The FDA classified the action as Class I, its most serious category.

Hospitals operating these pumps should follow Baxter's correction notice in full, including any interim instructions for checking that an infusion is running as programmed.

The recalled product

Product: Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Infusion Pump
Hazard: software-anomaly
system-error
infusion-pump
class-i
Affected units: 10,101

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 05413765852428
All Serial Numbers

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · software anomaly