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.
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-0958-2026%22
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