Recall Z-2447-2025
Dexcom, Inc. · initiated July 24, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System
Codes / lots: Lot Code: UDI: SW12300 - 00386270001863
Reason for recall
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.
FDA-determined cause: Software design
Action taken
On 07/24/2025, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION" via in-app messaging informing users that a software bug was identified with users using the following app version: -Dexcom ONE+ iOS/Android App version 1.4 and all earlier versions, -Dexcom G7 iOS/G7 Watch iOS/Android App versions 2.8 and earlier The software bug can cause an issue where, when a transmitter error occurs, the app terminates the sensor session and prompts the user to "start a new sensor" without providing a "sensor failed" alert. Customer are instructed that an upgrade from app version version the affected software versions is mandatory and users will not be able to to use the affected app versions after August 20, 2025. To update their app now to continue to use the app: 1. Tap Update App to go to the app store. 2. Install the latest Dexcom ONE+ app version or Dexcom G7 app version 3. Open the Dexcom ONE+ app or the G7 app If assistance is needed, contact Technical Support U.S.: 1-844-478-1600 Global: Find local Technical Support contact information at Dexcom.com
Details
- Recall number
- Z-2447-2025
- Initiated
- July 24, 2025
- Posted by FDA
- September 4, 2025
- Product code
- QBJ – Integrated Continuous Glucose Monitoring System, Factory Calibrated
- Quantity
- 907842
- Distribution
- SW12299 G7 Android CGM App Worldwide Distribution - US Nationwide and the countries of Andorra, United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands…
- Recalling firm
- Dexcom, Inc., San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2446-2025 Class I | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS… | 07/24/2025Open, Classified |
| Z-2448-2025 Class I | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS… | 07/24/2025Open, Classified |
| Z-2449-2025 Class I | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+…The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS… | 07/24/2025Open, Classified |
| Z-2450-2025 Class I | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+…The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS… | 07/24/2025Open, Classified |