Recall Z-2496-2025— Medtronic MiniMed, Inc.

Name: FDA recall Z-2496-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-16

Class II · Ongoing

Class II FDA medical device recall by Medtronic MiniMed, Inc., initiated 2025-06-16. It names one FDA 510(k) clearance: K242775. Product: InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users). Reason: 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..

Recalling firm: Medtronic MiniMed, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-16
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, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)

Reason for recall

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.

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