InPen App — Class II medical device recall Z-0958-2026

Ongoing recall by Medtronic MiniMed, Inc., reported 2025-12-24, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to

Recall number	`Z-0958-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Medtronic MiniMed, Inc., Northridge, CA, United States
Recall initiated	2025-11-13
Classified	2025-12-18
Reported by FDA	2025-12-24
Distributed	AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY
Countries outside the US	AT, BE, CH, CL, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HU, IE, IL, IS, IT, LU, NL, NO, PL, PT, RO, SE, ZA
Quantity	8,251
Reason classes	software
UPC / GTIN / UDI-DI	`00763000974596`
Model numbers	`MMT-8061`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0958-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.