Dexcom, Inc. has issued a correction for its Dexcom G7 Continuous Glucose Monitoring (CGM) Apps and Dexcom ONE+ CGM Apps due to a software design flaw. This change impacts users globally and is deemed critical by the FDA as the issue poses serious health risks.
What changed?
The affected apps include Dexcom G7 Android, iOS, watchOS versions 2.8.0 and earlier, and Dexcom ONE+ Android, iOS versions 1.4.0 and earlier. A software design error was discovered that prevents users from receiving “Sensor Failed” alerts when the sensor transmitter encounters a hardware or firmware failure. Instead, the app unexpectedly ends the sensor session and displays either a “Start Sensor” screen or “No active sensor” message without an alert notification.
This issue could lead to prolonged gaps in glucose data, critical alerts, and failure to detect severe hypoglycemia or hyperglycemia, putting users’ safety at significant risk. Though no injuries or fatalities have been reported, the situation is classified as the most serious type of recall by the FDA.
Who is affected?
This correction targets users of the Dexcom G7 and Dexcom ONE+ apps globally. It includes:
- Dexcom G7 Android, iOS, watchOS App versions 2.8.0 or earlier.
- Dexcom ONE+ Android, iOS App versions 1.4.0 or earlier.
Dexcom sent out an urgent notification to affected users on July 24, 2025, recommending immediate updates to the latest app versions to continue using the system safely and effectively.
Actions needed
Dexcom G7 App Users:
Download the latest version of the Dexcom G7 App:
- For iOS/watchOS users, use the App Store.
- For Android users, utilize the Google Play Store.
After installation, confirm the app upgrade by opening it on the smart device. Ensure compatibility with any other connected systems, such as automated insulin dosing devices.
Dexcom ONE+ App Users:
Similarly, update to the latest Dexcom ONE+ App version:
- For iOS users, download the update via the App Store.
- For Android users, use the Google Play Store.
Open the app to verify the update and reconnect the sensor and transmitter as prompted.
After August 20, 2025, users will be unable to use versions 2.8.0 or earlier (G7) and 1.4.0 or earlier (ONE+) without upgrading.
Purpose and implications
The Dexcom G7 and ONE+ CGM systems are designed to assist in managing diabetes by continuously monitoring glucose levels. These tools play essential roles in notifying users of trends, alerts, and critical levels of hypo or hyperglycemia, allowing for timely corrective measures. A failure in alert functionality compromises user safety, potentially leading to severe health consequences.
Both products are used by individuals aged two years and older, including pregnant individuals, in home and clinical settings. The urgency of this correction underscores the critical need for reliable functionality in such life-dependent systems.
How to report issues
Users facing difficulties with updating the app or encountering unresolved errors can reach out for support:
- U.S. customers: Contact Dexcom Technical Support at 1-844-478-1600.
- Global users: Visit Dexcom.com for region-specific contact information.
Adverse events or quality concerns can also be reported directly to the FDA via their MedWatch program.
Conclusion
This software correction is mandatory to ensure continuous and safe use of Dexcom’s CGM systems. Users are urged to complete the app updates promptly to avoid serious health risks arising from missed glucose data.
Disclaimer
This article provides information for clinical, regulatory, and healthcare professionals. It is not intended as medical, regulatory, or legal advice. Consult official resources for further guidance.
Mandatory FDA line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/continuous-glucose-monitor-apps-correction-dexcom-inc-issues-correction-g7-apps-and-one-apps-due