Home / Recalls / Medtronic MiniMed, Inc. / Z-2496-2025

Z-2496-2025 Class II Ongoing

Recalled by Medtronic MiniMed, Inc. — Northridge, CA

FDA device recall Z-2496-2025 was initiated by Medtronic MiniMed, Inc. on June 16, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 6816.

Recall Details

Product Type: Devices
Report Date: September 10, 2025
Initiation Date: June 16, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6816

Product Description

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

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.

Distribution Pattern

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.

Code Information

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

Other recalls by Medtronic MiniMed, Inc.

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Z-1742-2026 Class II — MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT (February 13, 2026)
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Z-1741-2026 Class II — MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT (February 13, 2026)