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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 InPen App Recalled for Software Errors in Insulin Reminders

Agency Publication Date: September 2, 2025
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Summary

Medtronic MiniMed, Inc. is recalling approximately 6,816 units of the InPen App for iOS and Android devices due to software design errors. These errors can cause the app to miss reminders for short-acting insulin doses or provide incorrect recommendations for correcting high blood sugar values. While the physical insulin pen still functions correctly for manual dosing and data recording, the app's software fails to provide necessary alerts, which was discovered during internal testing. No injuries or patient complaints have been reported in relation to this issue.

Risk

The software defect may prevent users from receiving critical insulin dose reminders or cause them to receive incorrect guidance for managing high glucose levels. This failure to alert the user can delay necessary diabetes treatment, potentially leading to high blood sugar (hyperglycemia).

What You Should Do

  1. This recall involves the Medtronic InPen App for iOS (model MMT-8060) and Android (model MMT-8061), specifically software versions ranging from 7.0.0 to 7.5.0.
  2. Check the software version currently installed on your mobile device by navigating to the app settings. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled version of the app for insulin dose reminders or glucose correction recommendations.
  4. 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 the manufacturer for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA).

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 (iOS Users)
Variants: iOS
Model / REF:
MMT-8060
UDI:
0763000B000122075

Affected software versions: 7.0.0, 7.1.0, 7.2.0 and 7.5.0

Product: InPen App (Android Users)
Variants: Android
Model / REF:
MMT-8061
UDI:
0763000B000122075

Affected software versions: 7.0.0, 7.0.1, 7.1.0, 7.1.1, 7.2.0 and 7.5.0

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97237
Status: Active
Manufacturer: Medtronic MiniMed, Inc.
Sold By: App Store; Google Play Store; Specialized medical distributors
Manufactured In: United States
Units Affected: 6816
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.