Medtronic Minimed, Inc.: Calculator, Drug Dose
Recall Summary Medtronic's MiniMed Go app (versions 1.0.0 and 1.1.0) has a software glitch where nighttime alerts for missed insulin doses or high blood sugar readings fail to notify users when the "Set day and night" feature is turned off. This could cause users to miss rapid-acting insulin doses without knowing it, potentially leading to dangerously high blood sugar levels. The app is available on both iPhone and Android devices and has been distributed across the US and several other countries worldwide.
- Recalling firm
- Medtronic MiniMed, Inc.
- Product
- MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
- Reason
- For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-16
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e38c7d54-d8de-4f4e-9f08-23861e0076e5