Z-2496-2025Class II

InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)

Name: Z-2496-2025 InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Creator: Medtronic MiniMed, Inc.
Published: 2025-06-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2025-06-16 / Open, Classified / root cause: software

FDA source

Medtronic MiniMed, Inc. began a recall of InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) on 2025-06-16. FDA classified it as Class II and gives the reason as "Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value...". 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-2496-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-16
Posted: 2025-09-02
Recalling firm: Medtronic, Inc.
Product: InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Product code: NDC Calculator, Drug Dose
Reason for recall: Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: On 6/16/2025, correction notices were emailed to customers who were asked to do the following: Actions Required: Users of InPen app software should update to version 7.5.1 or higher. For iOS Users - 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. - Open the App Store. - Tap your profile icon at the top of the screen. - Scroll to see pending updates. - Tap Update next to the InPen app icon. For Android Users - 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. - 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. Firm's 24-Hr Technical Support: 1-800-646-4633
Quantity in commerce: 6816
Distribution: International distribution to the countries of Argentina, Australia, Austria, Belgium, Bermuda, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Luxembourg, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Product codes and lots: UDI-DI: 0763000B000122075 CFN/Software Version: MMT-8060/7.0.0, 7.1.0, 7.2.0 and 7.5.0 MMT-8061/7.0.0, 7.0.1, 7.1.0, 7.1.1, 7.2.0 and 7.5.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2496-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2496-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02

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)