FDA Device recall Z-2496-2025
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
- FDA Device
- Class II
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class II recall of InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) by Medtronic Minimed, citing medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recomme….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2496-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-16 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Minimed |
| Distribution | GA |
Product
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Reason
Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.
Identifiers
| code_info | UDI-DI: 0763000B000122075 CFN/Software Version: MMT-8060/7.0.0, 7.1.0, 7.2.0 and 7.5.0 MMT-8061/7.0.0, 7.0.1, 7.1.0, 7.1.1, 7.2.0 and 7.5.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Medtronic Minimed
- Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062
FDA Device · Class II · 2026-10-14 · Medtronic Minimed - MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782
FDA Device · Class II · 2026-08-26 · Medtronic Minimed - MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
FDA Device · Class II · 2026-07-29 · Medtronic Minimed
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2496-2025%22
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