FDA Device recall Z-1964-2025
Baxter Novum IQ Syringe Pump, product code 40800BAXUS
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Baxter Novum IQ Syringe Pump, product code 40800BAXUS by Baxter Healthcare, citing 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 interfa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1964-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-12 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Reason
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.
Identifiers
| code_info | UDI/DI 05413765852428, All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1964-2025%22
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