The Recall Desk
Severity pendingFDA (Devices)·Z-2496-2025·Announced 2025-09-10

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

Pending LLM rewrite. Source: FDA_DEVICE Z-2496-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English 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.

The recalled product

Product
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Manufacturer
Medtronic MiniMed, Inc.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • 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
  • 7.1.1
  • 7.2.0 and 7.5.0

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category