InPen MMT-8061Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K242775); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 13, 2025Open, Classified

   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.

   Z-0958-2026 · Root cause: Software Design Change · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K242775. One submission often covers many models, so check the product and lot details in each record.

• Z-2496-2025 · Jun 16, 2025 · Open, Classified
  InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
• Z-1650-2025 · Mar 4, 2025 · Open, Classified
  InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA