Recall Ledger

Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 recall (Medtronic MiniMed, Inc.)

Medical deviceClass IIOngoing

Summary: Medtronic MiniMed, Inc. is recalling Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1 Product Description: The MiniMed Go app for iOS or MiniMed Go app for Android is compatible with the following components: " Simplera sens. Reason: A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating their app to version 1.2.1. The long-acting dose reminder is an optional feature that, when enabled, triggers a notification at the scheduled time to remind users to take their long-acting insulin dose. The issue was caused by a type cast exception during database migration that occurs upon app update to version 1.2.1 causing a silent failure that prevented the creation of new alerts. Failure to receive the long-acting dose reminder may result in missed or delayed insulin doses, potentially leading to hyperglycemia. Conversely, if users are uncertain whether they took their dose due to the missing reminder, inadvertent duplicate dosing may occur, potentially resulting in hypoglycemia.

What is being recalled

Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1 Product Description: The MiniMed Go app for iOS or MiniMed Go app for Android is compatible with the following components: " Simplera sensor " Instinct sensor " InPen smart insulin pen " Apple Watch [Optional] Continuous glucose monitoring (CGM) is a technology that allows you to continuously view glucose values. The app uses an inserted Simplera sensor CGM or Instinct sensor CGM with Bluetooth¿ wireless technology that converts small amounts of glucose from the interstitial fluid under the skin into an electronic signal. The sensors use that signal to provide sensor glucose (SG) values to the MiniMed Go app on a compatible mobile device. The app also provides alerts based on your SG levels and contains a user interface for entering data such as insulin, meals, exercise, blood glucose (BG) values, and uploading information to the CareLink" Personal website. The app is available to download from the Apple"* App Store"* or the Google Play"* Store. Component: No

Why

A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating their app to version 1.2.1. The long-acting dose reminder is an optional feature that, when enabled, triggers a notification at the scheduled time to remind users to take their long-acting insulin dose. The issue was caused by a type cast exception during database migration that occurs upon app update to version 1.2.1 causing a silent failure that prevented the creation of new alerts. Failure to receive the long-acting dose reminder may result in missed or delayed insulin doses, potentially leading to hyperglycemia. Conversely, if users are uncertain whether they took their dose due to the missing reminder, inadvertent duplicate dosing may occur, potentially resulting in hypoglycemia.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide - U.S. Nationwide distribution in the states of AL, CA, CT, FL, LA, MA, MD, NY, OH, PA, and TX. The countries of Austria, Belgium, Denmark, Finland, Germany, Iceland, Italy, Norway, Spain, Sweden, Switzerland, United Kingdom. (states named: Alabama, California, Connecticut, Florida, Louisiana, Massachusetts, Maryland, New York, Ohio, Pennsylvania, Texas)

How to tell if yours is affected

Lot Code: GTIN for MMT-8600, iOS: 00199150038978 GTIN for MMT-8601, Android: 00199150038985 UDI for MMT-8600, iOS: 00199150038978 UDI for MMT-8601, Android: 00199150038985 Software version 1.2.1

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-0265-2027
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedSeptember 2, 2026
ReportedOctober 28, 2026
CompanyMedtronic MiniMed, Inc.
Company locationNorthridge, CA, United States
Initiated byVoluntary: Firm initiated
Quantity623

More recalls from Medtronic MiniMed, Inc. · all medical device recalls · recalls from September 2026

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