Baxter Healthcare Corporation medical device recall: Novum IQ LVP
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97296
- Recall initiated
- Aug 4, 2025
- Classified by FDA
- Aug 29, 2025
- Posted in Enforcement Report
- Sep 10, 2025
- Recalling firm
- Baxter Healthcare Corporation
- Firm location
- Deerfield, IL, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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).
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Aug 4, 2025. FDA classified it 25 days later, on Aug 29, 2025. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: US distribution including Puerto Rico and OUS (International) Canada Baxter Healthcare Corporation has 279 recalls in our records.
Recalled products (3)
Z-2332-2025 Class I Ongoing
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Codes / lots: UDI/DI 05413765851797, All Serial Numbers
Quantity: 43,922 units
Z-2333-2025 Class I Ongoing
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Codes / lots: UDI/DI 05413765852428, All Serial Numbers
Quantity: 10,101 units
Z-2334-2025 Class I Ongoing
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
Codes / lots: UDI/DI N/A, All Serial Numbers
Quantity: 22703 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97296
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.