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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

Baxter Novum IQ Syringe Infusion Pumps Recalled for Gasket Installation Error

Agency Publication Date: March 21, 2025
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Summary

Baxter Healthcare Corporation is recalling 149 units of the Novum IQ Syringe Infusion System (Model REF 40800BAXUS) because a component called a gasket may have been installed incorrectly. This manufacturing defect could allow cleaning fluids or accidental IV fluid spills to leak into the pump's internal electronics. While no injuries have been reported, a pump failure could stop the delivery of critical medications to a patient. These units were distributed to hospitals and healthcare facilities across 19 states between 2022 and 2024.

Risk

An incorrectly installed gasket can allow liquids to enter the device's internal casing. This fluid ingress can cause the infusion pump to malfunction or fail completely, which may lead to an interruption or delay in the delivery of life-sustaining medications.

What You Should Do

  1. This recall involves the Baxter Novum IQ Syringe Infusion System, Model REF 40800BAXUS, with UDI/DI 05413765852428.
  2. Identify if your device is affected by checking the serial number located on the device label. See the Affected Products section below for the full list of 149 affected serial numbers.
  3. Stop using the recalled device immediately to prevent potential malfunction.
  4. Contact Baxter Healthcare Corporation or your authorized distributor to arrange for the return, replacement, or corrective servicing of the affected equipment.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions or wish to report a device failure.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Baxter NovumIQ Syringe INFUSION SYSTEM (REF 40800BAXUS)
Model / REF:
40800BAXUS
Serial Numbers (149):
02A220600103
02A221100387
02A240800201
02A230300471
02A240800161
02A220600112
02A230100474
02A240800343
02A230400357
02A240800175
02A220700259
02A230200471
02A240800710
02A230600165
02A240800223
02A220700176
02A230200487
02A240900081
02A230600175
02A240800513
02A220700349
02A230300030
02A240900133
02A230600176
02A240800577
02A220700268
02A230300117
02A240900265
02A230600255
02A240900261
02A220700081
02A230300125
02A240900277
02A230600256
02A240900421
02A220700140
02A230300132
02A240900285
02A230600618
02A240900742
02A220700351
02A230300146
02A240900287
02A230700137
02A240900746
02A220700409
02A230300275
02A240900282
02A241000576
02A240901067
UDI:
05413765852428

Quantity affected: 149 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96388
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Baxter Healthcare Corporation; Hospital supply channels
Manufactured In: United States
Units Affected: 149 units
Distributed To: Arkansas, California, Florida, Iowa, Indiana, Louisiana, Missouri, Montana, North Carolina, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia

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.