Insulin pen app recalled over notifications lost after reinstalling the app
Medtronic MiniMed is recalling 8,251 units of the InPen App for Android because reinstalling the app deletes the notification override permission, so audible and vibratory alerts are not received.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states missed notifications may lead to delayed insulin therapy and hyperglycemia, and no injuries are reported.
Plain-English summary
The InPen App, model MMT-8061 for Android users, software versions 7.5.0, 7.5.1 and 8.0.0, from Medtronic MiniMed, Inc., is being recalled. The product carries UDI-DI 00763000974596.
When the app is uninstalled and reinstalled, an insulin pen software issue causes the Choose Notification Style screen not to show during setup, so users cannot choose to allow notifications to override phone settings when the phone is on mute or Do Not Disturb, and the previously set up override permission is deleted. As a result audible and vibratory notifications are not received, which the firm states may lead to delayed insulin therapy and hyperglycemia.
The record lists 8,251 units, distributed across Illinois, Arizona, Minnesota, Nebraska, Kansas, Tennessee, California, Florida, Texas, Washington, Missouri, North Carolina, New York, Wisconsin, Indiana, Maine, Connecticut, Rhode Island, Maryland, Pennsylvania, Oklahoma, Kentucky, Massachusetts, Delaware, Utah, Idaho and Virginia. The FDA has classified the action as Class II.
Users should follow Medtronic's instructions and check their notification settings after reinstalling the app.
The recalled product
- Product
- InPen App, Model/CFN Number: MMT-8061 (Android Users)
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Diabetes app
- Affected units
- 8,251
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Software Versions: 7.5.0
- 7.5.1
- and 8.0.0. UDI-DI: 00763000974596
Distribution
Related recalls
Same manufacturer · Medtronic MiniMed, Inc.
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- HighMedtronic MiniMed 780G Insulin Pumps Recalled for Chemical Damage Risk
FDA (Devices) · 2026-08-26
- SevereMedtronic MiniMed 670G Insulin Pumps Recalled Due to Chemical Damage Risk
FDA (Devices) · 2026-08-26
- HighMedtronic MiniMed 640G Insulin Pumps Recalled for Chemical Damage Risk
FDA (Devices) · 2026-08-26
- HighMiniMed Go App Recalled Due to Missed Insulin Alerts
FDA (Devices) · 2026-07-29
Same hazard · missed notification
See all →- HighMedtronic MyCareLink Patient Monitors Recalled for Remote Monitoring Issues
FDA (Devices) · 2018-01-31
Similar recalls
- HighInPen app recalled over software errors affecting insulin dose reminders
FDA (Devices) · 2025-09-10
- HighMiniMed Go App Recalled Due to Missed Insulin Alerts
FDA (Devices) · 2026-07-29
- HighMedtronic MiniMed Insulin Pumps Recalled for Missing Audio Alerts
FDA (Devices) · 2019-01-02
- HighInPen Smart Insulin Pen Recall Due to Incorrect Assembly
FDA (Devices) · 2025-04-30
- HighMedtronic Recalls MiniMed 630G Insulin Pumps Due to Keypad Malfunction
FDA (Devices) · 2017-06-28
- HighInsulin pumps recalled over errors that suspend insulin delivery
FDA (Devices) · 2026-02-11