The Recall Desk
CriticalFDA (Devices)·Z-2334-2025·Announced 2025-09-10

Novum IQ Syringe Pump recall due to software anomalies

Baxter Healthcare is recalling Novum IQ Syringe Pumps due to software defects that may cause blank Run screens or false motor movement errors. Approximately 22,703 units distributed in the US, Puerto Rico, and Canada are affected.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I medical device recall for an infusion pump with software defects affecting critical operational functions. Class I recalls indicate situations where there is a reasonable probability that use of the product will cause serious adverse health consequences.

Plain-English summary

Baxter Healthcare Corporation has issued a Class I recall of the Novum IQ Syringe Pump (Product Code 40700BAX) due to software anomalies in the device. The defects may result in a blank Run screen or a false motor movement system error.

Approximately 22,703 units of this infusion pump have been distributed in the United States (including Puerto Rico) and Canada. The recall applies to all serial numbers of the affected product.

Healthcare facilities and patients should be aware of this recall. Facilities should contact Baxter Healthcare Corporation for instructions on identifying and addressing potentially affected devices.

The recalled product

Product
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Infusion Pump
Hazard
  • software-anomaly
  • blank-screen
  • false-motor-error

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 N/A
  • All Serial Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category