Recall Z-2778-2026— Medtronic MiniMed, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic MiniMed, Inc., initiated 2026-06-16. It names one FDA 510(k) clearance: K253512. 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..
- Recalling firm
- Medtronic MiniMed, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-16
- Firm location
- Northridge, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.