RecallRadar

FDA Device recall Z-2778-2026

MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)

On 2026-07-29 the FDA classified a Class II recall of MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) by Medtronic Minimed, citing for MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2778-2026
ClassificationClass II
Statusongoing
Initiated2026-06-16
Published2026-07-29
Last updated2026-09-13 11:58 UTC
CompanyMedtronic Minimed
DistributionUS

Product

MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)

Reason

For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.

Identifiers

code_infoModel/UDI-DI: MMT-8600/00199150038978(10)1.1.0, MMT-8601/00199150038985(10)1.1.0 Software Versions: 1.0.0, 1.1.0

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2778-2026%22

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