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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Baxter Novum IQ Syringe Pump Recalled for Syringe Detection Issue

Agency Publication Date: June 12, 2025
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Summary

Baxter Healthcare Corporation has recalled 8,027 Novum IQ Syringe Pumps (product code 40800BAXUS) due to a design flaw that causes the device to incorrectly detect a syringe flange even when the pump is empty. This issue can cause the user interface to become stuck on the "Remove Syringe" screen after an infusion is complete or trigger a "Flange Sensor Failure" (System Error 21502). The recall specifically affects a subset of pumps manufactured or repaired after July 4, 2023.

Risk

The sensor failure can delay medical treatments or prevent the device from being used for subsequent infusions if the interface becomes stuck. While no injuries have been reported, a malfunction in medication delivery equipment could lead to interruptions in critical patient care.

What You Should Do

  1. This recall involves Baxter Novum IQ Syringe Pumps (product code 40800BAXUS) with UDI/DI 05413765852428 that were manufactured or repaired after July 4, 2023.
  2. Check the manufacture or repair records for your Novum IQ syringe pumps to determine if they fall within the affected timeframe. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Baxter Healthcare Corporation or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 for more information.

Your Remedy Options

๐Ÿ“‹Other Action

Clinical device correction/return

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Baxter Novum IQ Syringe Pump
Model / REF:
40800BAXUS
Serial Numbers:
All Serial Numbers
UDI:
05413765852428
Date Ranges: Manufactured or repaired after July 4, 2023

Affected units may trigger System Error 21502 (Flange Sensor Failure) or become stuck on the Remove Syringe screen.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96822
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Direct distribution to healthcare facilities
Manufactured In: United States
Units Affected: 8027 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.