Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM… Recall
Issued September 10, 2025 · Dexcom, Inc.
In September 2025, Dexcom, Inc. recalled the Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App . The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, 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, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
What you should do
- 1 Stop using Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Dexcom, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Dexcom, Inc.
- Category
- Health
- Recall date
- September 10, 2025
- Units affected
- Not reported
- Sold at
- SW12299 G7 Android CGM App Worldwide Distribution - US Nationwide and the countries of Andorra, United Arab Emirates, Austria, Australia,
- Recall number
- FDA-Z-2446-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Dexcom, Inc. has 1 recall in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.