InPen App, Model/CFN Number: MMT-8061 (Android Users)
FDA Recall #Z-0958-2026 — Class II — November 13, 2025
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.
Recalling Firm
Medtronic MiniMed, Inc. — Northridge, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
8251
Distribution
US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI, MD, PA, OK, KY, MA, DE, UT, ID, VA, MI, OH, LA, NJ, IA, MT, HI, AR, OR, SC, AL, CO, WY, VT, NV, GA, MS, SD, AK, WV, NH, ND, NM. OUS: Austria, Belgium, Chile, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, South Africa, Spain, Sweden, Switzerland, United Kingdom
Code Information
Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated