FDA Medical devices recall ·
Baxter Novum IQ Syringe Pump, product code 40800BAXUS recall
- Recall number
- Z-1964-2025
- Date
- (initiated May 12, 2025)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 8027 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Why was it recalled?
Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps '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 occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.
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 05413765852428, All Serial Numbers
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1964-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.