ClearanceBrief
Recall Z-2778-2026 ยท NDC Calculator, Drug Dose

Medtronic MiniMed, Inc.

MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)

DateJul 23, 2026 (initiated Jun 16, 2026)
StatusOpen, Classified
ReasonFor 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.
Root causeSoftware design
ActionOn 6/16/2026 In-App Push Notifications were sent to customers entitled, Important Field Safety Corrective Action required on your MiniMed Go app. informing them a software upgrade is available to ensure important nighttime notifications are received. Correction notices were also emailed to customers informing them to update to version 1.2.0 or higher. For iOS Users: To confirm the latest app version on your iOS device, follow the steps below: 1. Open the App Store. 2. Tap your profile icon at the top of the screen. 3. Scroll to see pending updates. 4. Tap Update next to the MiniMed Go app ic
Quantity3,465
DistributionWorldwide - 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, Fin
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K253512MiniMed Go App
Medtronic Minimed, Jan 8, 2026