FDA recall, , Moderate risk
Medtronic MiniMed Go App
The MiniMed Go app has a software defect that can cause missed or delayed insulin doses, potentially leading to hyperglycemia or hypoglycemia.
Summary by Recall Canary from the FDA notice
What happened
Medtronic MiniMed, Inc. recalled the MiniMed Go app for iOS and Android, software version 1.2.1, due to a software defect. Existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating their app to version 1.2.1.
The long-acting dose reminder is an optional feature that, when enabled, triggers a notification at the scheduled time to remind users to take their long-acting insulin dose.
The recall began on September 2, 2026, and was added to the FDA's Enforcement Report on October 22, 2026. The app is compatible with the Simplera sensor, Instinct sensor, InPen smart insulin pen, and Apple Watch, and is available for download from the Apple App Store or the Google Play Store.
Distribution included nationwide in the states of Alabama, California, Connecticut, Florida, Louisiana, Massachusetts, Maryland, New York, Ohio, Pennsylvania, and Texas, as well as the countries of Austria, Belgium, Denmark, Finland, Germany, Iceland, Italy, Norway, Spain, Sweden, Switzerland, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare these details with yours, then check the recall notice to see which units are recalled.
MiniMed Go app
- Model number
- MMT-8600 (iOS)MMT-8601 (Android)
Recall details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution in the states of Alabama, California, Connecticut, Florida, Louisiana, Massachusetts, Maryland, New York, Ohio, Pennsylvania, and Texas. The countries of Austria, Belgium, Denmark, Finland, Germany, Iceland, Italy, Norway, Spain, Sweden, Switzerland, United Kingdom.
- Company
- Medtronic MiniMed, Inc.
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99945
- Recall number
- Z-0265-2027
All recalls from Medtronic MiniMed, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
