Baxter Novum IQ Syringe Pump Recalled for Sensor Defect
Baxter is recalling certain Novum IQ syringe pumps due to a design flaw that may cause false syringe detection, resulting in the user interface becoming stuck on the 'Remove Syringe' screen.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a design defect in a critical medical infusion device that presents a real risk of operational failure and inability to deliver medications. No injuries or illnesses have been reported, qualifying this as a risk-of-harm scenario without realized harm.
Plain-English summary
Baxter Healthcare Corporation is recalling certain Baxter Novum IQ Syringe Pumps (product code 40800BAXUS) due to a design issue that may cause the pump to incorrectly detect the presence of a syringe when none is loaded.
When this occurs, the pump's user interface becomes stuck on the 'Remove Syringe' screen when an infusion is complete and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may also occur. This issue only affects pumps manufactured or repaired after July 4, 2023.
Approximately 8,027 units were distributed nationwide (UDI/DI 05413765852428; all serial numbers affected). Affected healthcare facilities should contact Baxter Healthcare Corporation for guidance on addressing this issue.
The recalled product
- Product
- Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- sensor-failure
- design-defect
- operational-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 05413765852428
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03