Summary
The FDA issued a Class II for MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) by Medtronic MiniMed, Inc.. 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,.
Details
Source
Device Recall
External ID
Z-2778-2026
Action Date
2026-07-29
Status
Ongoing
Category
device
Product Description
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Lot/Code Info: 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
Quantity Affected: 3,465
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-16
Company
Northridge, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 373 device-related FDA actions this month.
Medtronic MiniMed, Inc. has 45 FDA actions in our database, including 39 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic MiniMed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic MiniMed, Inc. have FDA actions?
Medtronic MiniMed, Inc. has 45 FDA actions in our database, including 39 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2778-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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