CLASS I ONGOING Device recall · Reported 20 Aug 2025 · FDA Enforcement Report

Baxter Novum IQ Large Volume Pump, Product recalled by Baxter Healthcare

Baxter Healthcare is recalling Baxter Novum IQ Large Volume Pump, Product, distributed nationwide in the US. The recall was initiated on 14 Jul 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI/DI 05413765851797, All Serial Numbers

Quantity recalled36705 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2173-2025
FDA event ID: 97164
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class I
Status: Ongoing
Recall initiated: 14 Jul 2025
FDA classified: 14 Aug 2025
Reported: 20 Aug 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

14 Jul 2025	Recall initiated by company
14 Aug 2025	Classified by FDA	+31 days
20 Aug 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

Is Baxter Novum IQ Large Volume Pump, Product recalled?

Yes. Baxter Healthcare recalled Baxter Novum IQ Large Volume Pump, Product on 14 Jul 2025. The recall is Class I and its status is Ongoing. Recall number Z-2173-2025.

Why was it recalled?

Which lots are affected?

UDI/DI 05413765851797, All Serial Numbers

Where was it sold?

Worldwide distribution - US Nationwide and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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