FDA Medical devices recall ·

Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump recall

This is an FDA Class I recall — the most serious type.

Recall number
Z-2332-2025
Date
(initiated August 4, 2025)
Company / brand
Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States
Category
Medical devices › Class I
Classification
Class I
Status
Ongoing
Units affected
43,922 units
Hazard tags
Software
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump

Why was it recalled?

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

UDI/DI 05413765851797, All Serial Numbers

Distribution

US distribution including Puerto Rico and OUS (International) Canada

States: Puerto Rico

What does Class I mean?

Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Source: FDA (medical devices), recall Z-2332-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.