This recall involves correcting certain devices through a software update and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.

Affected Product

Product Names:

Dexcom G7 Continuous Glucose Monitoring (CGM) Android App
Dexcom G7 CGM iOS App
Dexcom G7 CGM watchOS App
Dexcom ONE+ CGM Android App
Dexcom ONE+ CGM iOS App

The affected App versions include the Dexcom G7 Android, iOS, watchOS Apps with versions 2.8.0 or earlier and the Dexcom ONE+ CGM Android, iOS Apps with versions 1.4.0 or earlier.

What to Do

On July 24, 2025, Dexcom sent all affected customers an Urgent Medical Device Correction Notification recommending the following actions.

Users of Dexcom G7 iOS / G7 Watch iOS / Android App versions 2.8 and earlier:

A design error was identified within App version 2.8, and all earlier versions.
Upgrading from App version 2.8 or earlier is mandatory and you will not be able to use App version 2.8 or earlier after August 20, 2025.

Update your app now to continue using the app:

Tap Update App to go to the App store.
Install the latest Dexcom G7 App version.
Open the Dexcom G7 App.

Users of Dexcom ONE+ iOS / Android App versions 1.4 and earlier:

A design error was identified within App version 1.4, and all earlier versions.
Upgrading from App version 1.4 or earlier is mandatory and you will not be able to use App version 1.4 or earlier after August 20, 2025.

Update your App now to continue using the App:

Tap Update App to go to the App store.
Install the latest Dexcom ONE+ App version.
Open the Dexcom ONE+ App.

Reason for Correction

Dexcom is correcting the Dexcom G7 App and Dexcom ONE+ App which contain a software design error that leads to a missed “Sensor Failed” alert when the sensor’s transmitter encounters a hardware/firmware failure. The affected App ends the CGM sensor session, stops reporting glucose values and displays the “Start Sensor” screen or “No active sensor” message without alerting the user.

The failure to alert the user of a failed transmitter may result in the user being unaware of extended periods of missed glucose data, notifications, alerts and alarms, which may result in a delay in treatment of prolonged episodes of severe hypoglycemia or hyperglycemia.

The use of affected product may cause serious adverse health consequences, including hypo/hyperglycemia and death.

There have been no reported injuries or reports of death related to this issue.

Device Use

The Dexcom G7 Continuous Glucose Monitoring (CGM) System is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older. The Dexcom G7 CGM provides glucose readings, trends, alerts and notifications that are displayed on the Dexcom G7 Receiver or on a compatible smart device using the Dexcom G7 CGM Apps (Android, iOS, watchOS). The Dexcom G7 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems.

The Dexcom ONE+ Continuous Glucose Monitoring System (Dexcom ONE+) is a glucose monitoring system indicated for continuously measuring glucose in the interstitial fluid in persons ages 2 years and older, including pregnant women. The Dexcom ONE+ provides glucose readings, trends, alerts and notifications that are displayed on the Dexcom ONE+ Receiver or on a compatible smart device using the Dexcom ONE+ CGM Apps (Android, iOS). Dexcom ONE+ also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Dexcom ONE+ is intended for use by patients at home and in healthcare facilities.

Contact Information

Customers in the U.S. with questions about this recall should contact Dexcom Technical Support at 1-844-478-1600.

For Global customers: Find local Technical Support contact information at Dexcom.com.

Additional FDA Resources (listed in order of most to least recent):

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.