FDA Device Recall Z-2332-2025

Baxter Healthcare Corporation · Deerfield, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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

Lot / serial / GTIN: UDI/DI 05413765851797, All Serial Numbers

Quantity: 43,922 units

Reason for recall

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).

Recall record

Recall number: Z-2332-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US distribution including Puerto Rico and OUS (International) Canada
Recall initiated: 2025-08-04
Classified by FDA Center: 2025-08-29
FDA published: 2025-09-10
Recalling firm: Baxter Healthcare Corporation
Firm location: Deerfield, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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