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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

Medtronic CareLink Clinic Software Recalled for Incorrect Glucose Graph Data

Agency Publication Date: November 25, 2025
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Summary

Medtronic MiniMed, Inc. is recalling 12,126 units of its CareLink Clinic software (version 4.2B) because a software error causes the 24-hour Sensor Glucose Overview Graph to display incorrect information. The affected software was available to clinics and patients in the United States and internationally between August 21, 2025, and October 4, 2025. Because the graph displays inaccurate glucose data, patients and healthcare providers may make incorrect treatment decisions.

Risk

Relying on incorrect glucose data to manage diabetes can lead to hypoglycemia (dangerously low blood sugar) or hyperglycemia (high blood sugar), both of which can result in serious medical complications or emergencies.

What You Should Do

  1. This recall involves Medtronic CareLink Clinic software (Model MMT-7350), specifically software version 4.2B used by healthcare providers and clinical facilities.
  2. Check your clinic's system to determine if you are running software version 4.2B. This version was made available between August 2025 and October 2025.
  3. Stop using the 24-hour Sensor Glucose Overview Graph in version 4.2B of the CareLink Clinic software to make any medical therapy decisions.
  4. Stop using the recalled product. Contact Medtronic MiniMed, Inc. or your distributor to arrange for a software correction, update, or further technical instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Software correction or update.

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

Affected Products

Product: CareLink Clinic Software (Version 4.2B)
Variants: Version 4.2B
Model / REF:
MMT-7350
UDI:
0763000B00008748K
Date Ranges: US Availability: September 4, 2025 to October 3, 2025, International Availability: September 11, 2025 to October 4, 2025, US Clinical Availability: August 21, 2025 to October 3, 2025, International Clinical Availability: August 21, 2025 to October 4, 2025

Software error causing incorrect data on the 24-hour Sensor Glucose Overview Graph.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97873
Status: Active
Manufacturer: Medtronic MiniMed, Inc.
Sold By: Medtronic; Hospitals; Diabetes Clinics; Endocrinology Offices
Manufactured In: United States
Units Affected: 12126
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.