Medtronic MiniMed, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2496-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 16, 2025

Date Posted: September 10, 2025

Recall Number: Z-2496-2025

Event ID: 97237

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.

Status: Ongoing

Product Quantity: 6816

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated