Agency classClass IIOur severity:High FDA (Devices)·Z-3066-2026·Announced 2026-09-09

Baxter Novum IQ Syringe Pump Recalled for Software Infusion Issue

Baxter Healthcare is recalling four Novum IQ Syringe Pump loaner units due to a software issue that may occur during multi-syringe infusions.

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: The recall is classified as FDA Class II and involves a medical device with a potential risk of harm (incorrect infusion volume) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Baxter Healthcare Corporation is recalling four units of the Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL. The recall is due to a software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

The affected units were distributed nationwide in the United States, including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The recall covers all serial numbers associated with UDI-DI 00197886002300.

Healthcare facilities and users should contact Baxter Healthcare Corporation for instructions on how to address the software issue. The source text does not specify a particular action for consumers, but users should verify if their devices are affected by checking the model number and UDI-DI.

The recalled product

Product: Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Infusion Pump
Hazard: software-defect
incorrect-infusion
Affected units: 4

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 00197886002300
all serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 45 states specifically:

Same manufacturer · Baxter Healthcare Corporation

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