Z-0958-2026Class II

InPen App, Model/CFN Number: MMT-8061 (Android Users)

Name: Z-0958-2026 InPen App, Model/CFN Number: MMT-8061 (Android Users)
Creator: Medtronic MiniMed, Inc.
Published: 2025-11-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2025-11-13 / Open, Classified / root cause: software

FDA source

Medtronic MiniMed, Inc. began a recall of InPen App, Model/CFN Number: MMT-8061 (Android Users) on 2025-11-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0958-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-13
Posted: 2025-12-18
Recalling firm: Medtronic, Inc.
Product: InPen App, Model/CFN Number: MMT-8061 (Android Users)
Product code: NDC Calculator, Drug Dose
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.
Root cause tag: software
FDA 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 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 [email protected]
Quantity in commerce: 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, Poland, Portugal, Romania, South Africa, Spain, Sweden, Switzerland, United Kingdom
Product codes and lots: Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0958-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0958-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18

Product code NDC

K242775Class IIInPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed / cleared 2024-11-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)