Medtronic MiniMed, Inc. recalls MiniMed Go App

Recalling company

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 – may cause temporary or medically reversible health consequences

Recall date

Jun 16, 2026

Reported

Jul 29, 2026

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, Finland, Iceland, Norway, Sweden.

Status

Ongoing

Quantity

3,465

Lot / codes

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

Company location

Northridge, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-2778-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2778-2026 in the FDA Enforcement Report. Also see FDA recall press releases.