Safety Alert: Class II: 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.

healthClass IIRecalled on Sep 10, 2025

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

🔢 6816

Sold At: Medtronic MiniMed, Inc.(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.)

Recall #: FDA-DEVICE-Z-2496-2025

Source: FDA-ENFORCEMENT

Product Identification

Lot/Batch Codes:: 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

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Summary

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.

What to do next

1Stop using this product - may cause temporary or medically reversible health problems
2Check with retailer or manufacturer for recall status and remedy options
3Contact Medtronic MiniMed, Inc. for return or refund information
4Visit the official FDA recall page for complete details

Summaries only; always follow the official notice.