Medtronic MiniMed, Inc. recalls MiniMed Go App

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.

On 6/16/2026 In-App Push Notifications were sent to customers entitled, Important Field Safety Corrective Action required on your MiniMed Go app. informing them a software upgrade is available to ensure important nighttime notifications are received. Correction notices were also emailed to customers informing them to update to version 1.2.0 or higher. For iOS Users: To confirm the latest app version on your iOS device, follow the steps below: 1. Open the App Store. 2. Tap your profile icon at the top of the screen. 3. Scroll to see pending updates. 4. Tap Update next to the MiniMed Go app icon. For Android Users: To confirm the latest app version on your Android device, follow the steps below: 1. Open the Google Play Store. 2. Tap Menu, then select Manage apps & device. 3. Apps with an update available are labeled "Update available." You can also search for the MiniMed Go app. 4. Tap Update next to the MiniMed Go app icon. Acknowledge that you have read and understood the notification by clicking the acknowledgement button or visiting https://www.minimed.com/en-us/safety-notices/notice31-letter If you have further questions or need assistance, please call the firm's 24-Hour Technical Support line at 1-800-646-4633, option 1.

• FDA enforcement recordOfficial FDA database entry for Z-2778-2026
• FDA 510(k) clearance · K253512The device's official FDA premarket clearance record
• FDA device classification · NDCOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.1890The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medtronic MiniMed, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.