Recall Z-0958-2026 ยท NDC Calculator, Drug Dose
Medtronic MiniMed, Inc.
InPen App, Model/CFN Number: MMT-8061 (Android Users)
| Date | Dec 18, 2025 (initiated Nov 13, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software Design Change |
| Action | 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) Medtronic Minimed, Nov 12, 2024 |