Novum IQ recallZ-2333-2025 · Baxter Healthcare Corporation · initiated Aug 4, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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).
FDA root cause category: Software design (manufacturing process)
What the company is doing
Baxter issued an "URGENT MEDICAL DEVICE CORRECTION" to its consignees on 08/04/2025 via USPS first class mail. The notice described the problem, hazard involved, and actions to be Taken by customers: 1. Users should rely on their clinical judgment. When providing patient care involving high risk medications and/or critical illness, users should consider utilizing an alternate pump, if available and appropriate for the patient's treatment. 2. If an alternate pump is not available or appropriate for patient care you may continue to use the Novum IQ LVP and Novum IQ Syringe Pump consistent with the following actions: - If a blank Run screen is displayed during an infusion on the Novum IQ LVP, the user should open the door, press the tubing into load point 3, then load point 4, to turn the light green, and close the door. If a blank Run screen is displayed during an infusion on the Novum IQ Syringe Pump, the user should unload, then reload the syringe. If these actions do not resolve the blank screen, both LVP and Syringe Pump users should power-cycle the pump, select "Yes" to the new patient prompt, and reprogram the infusion. - To prevent a false motor movement system error, do not program the Novum IQ syringe pump to infuse below the Minimum Recommended Flow Rate for a syringe size of 10 mL or greater. 3. Acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. 4. Please forward a copy of this communication to any departments within your institution who use the affected product. 5. Print and post Attachment A in areas frequented by potential users. For general questions regarding this communication, or if you experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867 (select option 2, then option 2 again) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.
Recall details
- Recall number
- Z-2333-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 4, 2025
- Posted by the FDA
- Aug 29, 2025
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 10,101 units
- Product code
- FRN
- FDA submissions
- K242390
- Distribution
- US distribution including Puerto Rico and OUS (International) Canada
Product description
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Code information (models, lots, serial numbers)
UDI/DI 05413765852428, All Serial Numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Novum IQ 40800BAXUSBaxter Healthcare Corporation · Pump, infusion4 recalls348 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K242390 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Novum IQ 40800BAXUSLBaxter Healthcare Corporation · Pump, infusion, enteral1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97296).
- Z-2332-2025 · Open, ClassifiedNovum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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