FDA recall, , Moderate risk
MiniMed Go App
The MiniMed Go App may miss nighttime alerts, leading to missed insulin doses and increased hyperglycemia risk.
Summary by Recall Canary from the FDA notice
What happened
Medtronic MiniMed, Inc., of Northridge, California, is recalling the MiniMed Go App, models MMT-8600 (iOS) and MMT-8601 (Android), versions 1.0.0 and 1.1.0. For these versions, when the Set day and night feature is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime.
This could result in missed rapid-acting insulin doses without the user's knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.
The company began the recall on June 16, 2026, and the FDA added it to its Enforcement Report on July 23, 2026. The app was distributed nationwide in the United States and in several other countries, including Australia, Switzerland, Germany, Denmark, Spain, Finland, Iceland, Norway, and Sweden.
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?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
MiniMed Go App
- Model
- MMT-8600
- UDI-DI
- 00199150038978
- 00199150038985
From the FDA notice
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states and territories of PR, OH, WA, IL, NC, PA, VA, MN, ID, CA, UT, MI, NJ, MS, SC, CO, AZ, OR, AR, MO, TX, AL, FL, NY, IN, TN, IA, WI, MA, LA, OK, GA, KS, NM, CT, KY, NH, NV, MD and the countries of Australia, Switzerland, Germany, Denmark, Spain, Finland, Iceland, Norway, Sweden.
- Company
- Medtronic MiniMed, Inc.Northridge, California
- 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
- 99228
- Recall number
- Z-2778-2026
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
In FDA's weekly enforcement report
Summary updated