Recall Z-0958-2026— Medtronic MiniMed, Inc.

Name: FDA recall Z-0958-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-13

Class II · Ongoing

Class II FDA medical device recall by Medtronic MiniMed, Inc., initiated 2025-11-13. It names one FDA 510(k) clearance: K242775. Product: InPen App, Model/CFN Number: MMT-8061 (Android Users). Reason: 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..

Recalling firm: Medtronic MiniMed, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-11-13
Firm location: Northridge, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K242775 — InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed·cleared 2024-11-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

InPen App, Model/CFN Number: MMT-8061 (Android Users)

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.