The FDA identified a recent recall of smartphone apps for Dexcom (Nasdaq:DXCM) continuous glucose monitors (CGMs) as the most serious type.
This recall involves correcting certain devices through a software update. It does not involve removing them from where they are used or sold. Serious recalls can lead to serious injury or death without correction. However, Dexcom reports no injuries or deaths related to this issue to date.
According to the FDA notice, the company issued an urgent medical device correction related to a range of its CGM apps. Those include the G7 CGM apps for Android, iOS and watchOS, plus the Dexcom ONE+ Android and iOS apps. Affected versions include G7 app versions 2.8.0 or earlier and the ONE+ apps with versions 1.4.0 or earlier.
G7 is Dexcom’s latest-generation CGM offering for people ages 2 and older. The device notably connects with integrated automated insulin delivery systems. Dexcom ONE+ is indicated for continuously measuring glucose in the interstitial fluid in persons ages 2 years and older, including pregnant women.
On July 24, 2025, Dexcom told customers that it identified a design error in app versions. Both had mandatory updates made available last month.
The company said the error leads to a missed “Sensor Failed” alert when the sensor’s transmitter encounters a hardware/firmware failure. In this case, the 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.
Dexcom said the failure to aler tthe user may result in periods of missed glucose data, notifications, alerts and alarms. That can lead to a delay in treatment, resulting in hypo/hyperglycemia and death.
