Z-2778-2026 Class II Ongoing
FDA device recall Z-2778-2026 was initiated by Medtronic MiniMed, Inc. on June 16, 2026 and is designated Class II. Reason for recall: 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 durin… The recall status is ongoing. Affected quantity: 3,465.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- June 16, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,465
Product Description
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Model/UDI-DI: MMT-8600/00199150038978(10)1.1.0, MMT-8601/00199150038985(10)1.1.0 Software Versions: 1.0.0, 1.1.0