# FDA recall Z-1964-2025

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2025-05-12.

## Product

Baxter Novum IQ Syringe Pump, product code 40800BAXUS,

## Reason for recall

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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1964-2025
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-12
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1964-2025

## Citation

> AI Analytics. FDA recall Z-1964-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1964-2025. Source: US FDA. Licensed CC0.

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