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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/Diagnostic Equipment

Baxter Spectrum IQ Infusion Pumps Recalled for Testing Failure

Agency Publication Date: February 13, 2026
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Summary

Baxter Healthcare Corporation is recalling five Spectrum IQ Infusion Pumps because they were released to the market without undergoing complete safety testing, including critical occlusion alarm testing. These pumps are used in healthcare settings to deliver fluids, such as nutrients and medications, into a patient's body in controlled amounts. Without proper testing, there is no assurance that the pump's alarms will sound correctly if the fluid line becomes blocked, which could lead to an interruption or delay in therapy. Consumers and healthcare facilities should contact Baxter immediately to arrange for the return or correction of the affected units.

Risk

The failure to perform occlusion alarm testing means the device may not alert medical staff if the infusion line is blocked. This could result in a patient receiving an incorrect dose of medication or a complete interruption of life-sustaining treatment, potentially leading to serious injury or death.

What You Should Do

  1. Stop using the recalled Spectrum IQ Infusion Pump (Model 3570009) immediately.
  2. Check your device for serial numbers 3815663, 3823468, 3824743, 3825234, or 3825599 and GTIN 00085412610900.
  3. Contact Baxter Healthcare Corporation or your authorized distributor to arrange for the return, replacement, or correction of the affected pump.
  4. Call the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions or need to report an issue.

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 Pumpby Spectrum IQ
Model / REF:
3570009
Serial Numbers:
3815663
3823468
3824743
3825234
3825599
Lot Numbers:
Code
GTIN:
00085412610900

One unit per carton.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98306
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: authorized distributors
Manufactured In: United States
Units Affected: 5
Distributed To: Ohio

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.