{"recall":{"id":"fda-device-99945","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medtronic MiniMed, Inc. recalls Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS)","firm":"Medtronic MiniMed, Inc.","date":"2026-09-02","reported":"2026-10-28","status":"Ongoing","classification":"Class II","products":[{"name":"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","code":"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","quantity":"623","number":"Z-0265-2027","classification":"Class II"}],"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"623","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99945","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e927df1c4ebdb881","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99945","record":[{"status":"Ongoing","city":"Northridge","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99945","recalling_firm":"Medtronic MiniMed, Inc.","address_1":"18000 Devonshire St","address_2":"","postal_code":"91325-1219","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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.","recall_number":"Z-0265-2027","product_description":"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","product_quantity":"623","reason_for_recall":"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.","recall_initiation_date":"20260902","center_classification_date":"20261022","report_date":"20261028","code_info":"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","more_code_info":""}]}}