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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/Home Healthcare

Medtronic InPen Android App Recalled for Insulin Notification Software Issue

Agency Publication Date: December 18, 2025
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Summary

Medtronic MiniMed, Inc. is recalling 8,251 units of the InPen App (Model MMT-8061) for Android users. A software issue occurs when the app is uninstalled and then reinstalled, causing the setup screen for notification styles to be skipped. This defect prevents users from choosing to allow insulin notifications to override phone settings like mute or 'Do Not Disturb,' which can result in critical audible or vibrating alerts not being received. If you use this app, you should contact Medtronic or your healthcare provider to ensure your notification permissions are correctly configured.

Risk

Missing audible or vibrating notifications for insulin therapy can lead to delayed treatment and high blood sugar (hyperglycemia). This software defect specifically deletes previously set override permissions, making the device silent even when the user expects to be alerted during muted or quiet phone modes.

What You Should Do

  1. This recall affects the Medtronic InPen App for Android (Model MMT-8061) using software versions 7.5.0, 7.5.1, and 8.0.0.
  2. Identify if you are using an affected version by checking the 'About' or 'Settings' section of your InPen mobile application for the version number and UDI-DI 00763000974596.
  3. Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Medtronic for further instructions on how to resolve the notification issue.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: InPen App (Android Users)
Variants: Android OS
Model / REF:
MMT-8061
Lot Numbers:
Software Version 7.5.0
Software Version 7.5.1
Software Version 8.0.0
UDI:
00763000974596

Recall affects users who have uninstalled and reinstalled the application.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97904
Status: Active
Manufacturer: Medtronic MiniMed, Inc.
Sold By: Authorized Medical Distributors; Google Play Store
Manufactured In: United States
Units Affected: 8251
Distributed To: Illinois, Arizona, Minnesota, Nebraska, Kansas, Tennessee, California, Florida, Texas, Washington, Missouri, North Carolina, New York, Wisconsin, Indiana, Maine, Connecticut, Rhode Island, Maryland, Pennsylvania, Oklahoma, Kentucky, Massachusetts, Delaware, Utah, Idaho, Virginia, Michigan, Ohio, Louisiana, New Jersey, Iowa, Montana, Hawaii, Arkansas, Oregon, South Carolina, Alabama, Colorado, Wyoming, Vermont, Nevada, Georgia, Mississippi, South Dakota, Alaska, West Virginia, New Hampshire, North Dakota, New Mexico

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.