Reported Dec 24, 2025 · Ongoing
InPen App, Model/CFN Number: MMT-8061 (Android Users)
Medtronic MiniMed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic MiniMed, Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219
Is this the product you have?
- InPen App
- Model/CFN NumberMMT-8061 (Android Users)
- Lot codes and dates
- Software Versions
7.5.07.5.1and 8.0.0
- UDI-DI00763000974596
- Software Versions
- Amount recalled
- 8251
Where it was sold
Why it was recalled
When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.
This product could cause temporary or reversible health problems — stop using it.
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