# FDA recall Z-0958-2026

> **Medtronic MiniMed, Inc.** · Class II · device recall initiated 2025-11-13.

## Product

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.

## 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

## Key facts

- **Recall number:** Z-0958-2026
- **Recalling firm:** Medtronic MiniMed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-13
- **Report date:** 2025-12-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northridge, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0958-2026

## Citation

> AI Analytics. FDA recall Z-0958-2026. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-0958-2026. Source: US FDA. Licensed CC0.

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