Baxter Novum IQ Syringe Pump — Class II medical device recall Z-3065-2026
Ongoing recall by Baxter Healthcare Corporation, reported 2026-09-09, distributed nationwide. A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty
| Recall number | Z-3065-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2026-08-11 |
| Classified | 2026-08-31 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 14,601 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05413765852428 |
| Model numbers | 40800BAXUS |
Product
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
Reason for recall
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3065-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.