Medtronic MiniMed, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0958-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 13, 2025

Date Posted: December 24, 2025

Recall Number: Z-0958-2026

Event ID: 97904

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.

Status: Ongoing

Product Quantity: 8251

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated