Dexcom, Inc. is recalling approximately 2,429,443 units of software for the Dexcom G7 and Dexcom ONE+ Continuous Glucose Monitoring (CGM) systems. The recall affects the G7 mobile apps (versions 2.8.0 and earlier) and ONE+ mobile apps (versions 1.4.0 and earlier) across Android, iOS, and Apple Watch platforms. The apps may fail to provide a "Sensor Failed" alert when a hardware or firmware failure occurs, which can cause the app to stop reporting glucose values without warning.
If the app fails to alert you that the sensor has stopped working, you may miss detection of dangerously high or low blood sugar levels. This failure to report values can lead to a delay in necessary medical treatment for hyperglycemic or hypoglycemic events.
You have 2 options:
Software version 2.8.0 and earlier
Software version 2.8.0 and earlier
Software versions 2.8.0 and earlier; installed via the iOS phone app.
Software versions 1.4.0 and earlier
Software versions 1.4.0 and earlier
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.