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fda_recall · device_recall · high

Medtronic MiniMed, Inc. — Class II recall: InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)

Event date
2025-09-10 00:00:00Z
Observed
2026-07-16 23:20:07Z
Source ID
Z-2496-2025
Payload hash
86cc143fee2b3a43b1c8d830…

Summary

Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM… Status: Ongoing.

Entities

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Frequently asked questions

Has Medtronic MiniMed, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 38 total FDA actions tied to Medtronic MiniMed, Inc.: 0 warning letters, 38 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2025-09-10; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2025). Medtronic MiniMed, Inc. — Class II recall: InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medtronic-minimed-inc-z-2496-2025
MLA
"Medtronic MiniMed, Inc. — Class II recall: InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-medtronic-minimed-inc-z-2496-2025.
Chicago
Argus HQ Research. "Medtronic MiniMed, Inc. — Class II recall: InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-medtronic-minimed-inc-z-2496-2025.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_medtronic_minimed_inc_z_2496_2025_2025,
  title = {Medtronic MiniMed, Inc. — Class II recall: InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medtronic-minimed-inc-z-2496-2025},
  note = {Accessed: July 23, 2026}
}

Informational only. Not legal, financial, or medical advice.

Medtronic MiniMed, Inc. — Class II recall: InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) · Argus HQ