# Class II recall Z-0265-2027: Medtronic MiniMed, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0265-2027 |
| Recalling firm | Medtronic MiniMed, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | 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 conver |
| 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 d |
| Quantity | 623 |
| Distribution | 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 initiated | 2026-09-02 |
| Reported | 2026-10-28 |
| Firm location | Northridge, CA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 7 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0265-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.