The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2496-2025·Announced 2025-09-10

InPen app recalled over software errors affecting insulin dose reminders

Medtronic is recalling the InPen App for iOS and Android because software design errors could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. 6,816 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a missed insulin dose reminder is a potential harm and no injuries are reported.

Plain-English summary

The InPen App, CFN MMT-8060 for iOS users and MMT-8061 for Android users, UDI-DI 0763000B000122075, is being recalled across software versions including 7.0.0, 7.1.0, 7.2.0 and 7.5.0. The recall covers 6,816 units distributed internationally, including Argentina, Australia, Austria, Belgium, Bermuda, Chile and the Czech Republic.

Medtronic MiniMed, Inc. is recalling the app because of software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. The company states the issue does not affect insulin delivery, long-acting insulin dose reminders or CGM alerts, and that users can still use the pen itself to calculate a dose, deliver insulin and record the dose. The FDA classified the action as Class II.

Users should follow Medtronic's instructions for updating the app and continue to monitor glucose as directed by their clinician.

The recalled product

Product
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Manufacturer
Medtronic MiniMed, Inc.
Category
Medical Device — Diabetes Management
Hazard
Affected units
6,816

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.

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