FDA Device recall Z-0958-2026
InPen App, Model/CFN Number: MMT-8061 (Android Users)
- FDA Device
- Class II
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class II recall of InPen App, Model/CFN Number: MMT-8061 (Android Users) by Medtronic Minimed, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0958-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-13 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Minimed |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
InPen App, Model/CFN Number: MMT-8061 (Android Users)
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.
Identifiers
| code_info | Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0958-2026%22
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