Medtronic MiniMed, Inc. recalls InPen App

Recalling company

Medtronic MiniMed, Inc.

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Nov 13, 2025

Reported

Dec 24, 2025

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

Status

Ongoing

Quantity

8251

Lot / codes

Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596

Company location

Northridge, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-0958-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0958-2026 in the FDA Enforcement Report. Also see FDA recall press releases.