Recall Z-2778-2026
- Recall number
- Z-2778-2026
- Event number
- 99228
- Firm
- Medtronic MiniMed, Inc.
- Firm FEI
- 3003166194
- Product code
- NDC
- Status
- Open, Classified
- Initiated
- 2026-06-16
- Posted
- 2026-07-23
- Root cause
- Software design
- 510(k) numbers
- K253512, K203434, K141929, K230813, K081388, K190487, K172177, K242066, K142123, K043529, K192841, K082512, K854249, K011571, K053137, K132547, K171450, K113853, K000418, K200443, K061110, K232451, K260910, K882001, K150910, K221924, K241088, K181327, K160949, K851573
Product#
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.