InPen App — Class II medical device recall Z-2496-2025
Ongoing recall by Medtronic MiniMed, Inc., reported 2025-09-10, distributed in GA. Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that co
| Recall number | Z-2496-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic MiniMed, Inc., Northridge, CA, United States |
| Recall initiated | 2025-06-16 |
| Classified | 2025-09-02 |
| Reported by FDA | 2025-09-10 |
| Distributed | GA |
| Countries outside the US | AE, AR, AT, AU, BE, BM, CH, CL, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IS, IT, LU, NL, NO, NZ, PL, PT, RO, RS, SA, SE, SG, ZA |
| Quantity | 6,816 |
| Reason classes | software |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2496-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.