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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 Spectrum IQ Infusion Pump Recalled for Excessive Therapy Risk

Agency Publication Date: August 22, 2025
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Summary

Baxter Healthcare Corporation has recalled 6 Spectrum IQ Infusion Pumps (Product Code 3570009) because an internal mechanical component may fail prematurely. A grease applied to the device's motor gears and cam can break down quickly, leading to wear that causes the pump to deliver more medication than intended. This resulting "excessive therapy" could pose serious health risks to patients depending on the medication being delivered.

Risk

The breakdown of gear grease leads to premature wear of the mechanism assembly, which can cause the pump to malfunction and deliver too much medication or fluid. This excessive therapy can lead to medication overdose or other infusion-related complications.

What You Should Do

  1. This recall affects 6 units of the Spectrum IQ Infusion Pump (Product Code 3570009) with the following serial numbers: 3815255, 3815261, 3815265, 3815266, 3815267, and 3815271.
  2. Stop using the recalled device immediately to prevent the risk of over-infusion.
  3. Contact Baxter Healthcare Corporation or your authorized distributor to arrange for the return, replacement, or correction of the affected infusion pumps.
  4. Call the FDA at 1-888-INFO-FDA (1-888-463-6332) if you have additional questions regarding medical device recalls.

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: Spectrum IQ Infusion Pump
Model / REF:
3570009
Serial Numbers:
3815255
3815261
3815265
3815266
3815267
3815271
UDI:
00085412610900

Recall Number: Z-2415-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97335
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: authorized medical distributors
Manufactured In: United States
Units Affected: 6 units
Distributed To: Arizona, Florida

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.