Recall Z-0958-2026
Medtronic MiniMed, Inc. · initiated November 13, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
InPen App, Model/CFN Number: MMT-8061 (Android Users)
Codes / lots: Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596
Reason for recall
When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.
FDA-determined cause: Software Design Change
Action taken
On 11/13/2025, correction notices were emailed to customers who were asked to update to version 8.0.1 or higher as soon as possible to resolve this issue. 1.Verify your app version: -On the home screen, navigate to the Settings menu (lower right corner). - Select Help and Support. - Note the App Version displayed. 2. If you are running versions 8.0.0, update to the latest version 8.0.1 or higher via the Google Play Store: - Open the Google Play Store. - Tap your profile icon at the top of the screen, then select Manage apps & device. - Tap Updates available or search for the InPen app. - Tap Update next to the InPen app icon. Electronically acknowledge that you have read and understand this notification and have followed the actions listed For questions, contact the firm's 24-Hour Technical Support line at 1-800-646-4633, option #1. The Customer Confirmation Form can also be emailed to the firm at rs.safetyinformation@medtronic.com
Details
- Recall number
- Z-0958-2026
- Initiated
- November 13, 2025
- Posted by FDA
- December 18, 2025
- Product code
- NDC – Calculator, Drug Dose
- Quantity
- 8251
- Distribution
- US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI, MD, PA, OK, KY, MA, DE, UT, ID, VA, MI, OH, LA, NJ, IA, MT, HI, AR, OR, SC, AL, CO, WY, VT, NV, GA, MS, SD, AK, WV, NH, ND, NM. OUS: Austria, Belgium, Chile, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway…
- Recalling firm
- Medtronic MiniMed, Inc., Northridge, CA