Lower risk Medical device recall · FDA · Published November 13, 2025

Medtronic InPen App (MMT-8061) may cause missed insulin alerts on Android

Medtronic recalls InPen App version 7.5.0-8.0.0 for Android users. Uninstalling and reinstalling resets notification permissions, risking missed insulin alerts and hyperglycemia.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0958-2026Medical device Medtr: a short, human brand name for headings (e.g. "Trsmima") ›

Lower-risk 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.

Take action

Contact the company

Recalling firmMedtronic MiniMed, Inc.18000 Devonshire St · Northridge, CA 91325-1219

✎ GovInfoNow plain-language explainer

Medtronic is recalling its InPen App for Android users with model numbers MMT-8061. The app may reset notification permissions when uninstalled and reinstalled, causing users to miss insulin alerts and potentially leading to high blood sugar levels. Read more at govinfonow.com/recall/50665-medtronic-inpen-app-mmt-8061-may-cause-missed-insulin-alerts.

Source Summary by GovInfoNow · govinfonow.com/recall/50665-medtronic-inpen-app-mmt-8061-may-cause-missed-insulin-alerts · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0958-2026

Cite this page

“Medtronic InPen App (MMT-8061) may cause missed insulin alerts on Android.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50665-medtronic-inpen-app-mmt-8061-may-cause-missed-insulin-alerts. Based on FDA recall #Z-0958-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0958-2026%22&limit=1).

The FDA announced on November 13, 2025, that Medtronic MiniMed, Inc. is recalling the InPen App (Model/CFN Number: MMT-8061) for Android users due to a software issue that may prevent notification overrides during setup. This defect could lead to delayed insulin therapy and hyperglycemia.

How to tell if you have it

InPen App, Model/CFN Number: MMT-8061 (Android Users)
Software Versions: 7.5.0, 7.5.1, and 8.0.0
UDI-DI: 00763000974596

The hazard

According to the FDA, when the app is uninstalled and reinstalled, a software issue causes the Choose Notification Style Screen to not show during setup. This prevents users from choosing to allow notifications to override phone settings when on mute or Do Not Disturb, and previously set up override permission is deleted. As a result, audible and vibratory notifications are not received, which may lead to delayed insulin therapy and hyperglycemia.

Context

GovInfoNow's records show Medtronic MiniMed, Inc. has 13 other recalls on record since November 15, 2023. Other recent recalls of similar products include Medtronic MiniMed 670G Insulin Pump Recall (July 13, 2026), Medtronic MiniMed Go App Version 1.0.0/1.1.0 May Cause Missed Insulin Doses (June 16, 2026), and Medtronic MiniMed 780G Insulin Pump Recall (May 27, 2026). FDA's MAUDE device-report database contains 20 reports in FDA's MAUDE database naming InPen App received since November 2024.

How to tell if you have this one

Check your InPen App version in the app store. The affected model is MMT-8061 with software versions 7.5.0, 7.5.1, and 8.0.0. The UDI-DI number is 00763000974596.

Brand
Medtr: a short, human brand name for headings (e.g. "Trsmima")
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check App Version
Look for the app version in the Google Play Store or Apple App Store to confirm if it's 7.5.0, 7.5.1, or 8.0.0.
Update App
Update to the latest version of the InPen App to fix notification permissions.

Where it went and when

Where it was distributed

Distributed in 50 states, and outside the U.S.

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 41 days after the firm started it.

Nov 13, 2025Firm started the recall
Dec 18, 2025FDA classified it Class II
Dec 24, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to do anything if I don't use the app?

No action is needed if you don't use the InPen App or have a different app version.

Similar recalls

Other Medtr: a short, human brand name for headings (e.g. "Trsmima") recalls

Keep exploring

More Medtr: a short, human brand name for headings (e.g. "Trsmima") recalls

Link to this recall

<a href="https://govinfonow.com/recall/50665-medtronic-inpen-app-mmt-8061-may-cause-missed-insulin-alerts">Medtronic InPen App (MMT-8061) may cause missed insulin alerts on Android (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0958-2026 (November 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0958-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.