Glucose Monitor Recall: Dexcom G7 US Retail Sensor/Transmitter
Announced 2026-07-01 · FDA
The recall affects the Dexcom G7 CGM System and Dexcom ONE+ CGM System apps on iOS, watchOS, and Android, versions 2.8.0 or earlier and 1.4.0 or earlier respectively. The affected app does not provide the expected 'Sensor Failed' alert when the transmitter reports a 'transmitterFailed' error, and instead ends the sensor session and may show 'Start Sensor' or 'No active sensor' without alerting the user. The recall has worldwide distribution, including US nationwide, and lists Lot Code: UDI SW12300 - 00386270001863.
| Brand | Dexcom, Inc. |
|---|---|
| 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 |
| Reason | 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. |
| Severity | critical |
| Units affected | 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, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa SW12300 G7 iOS CGM App Worldwide Distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa SW14245 Dexcom ONE+ Android Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Israel, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden SW14244 D1G7 iOS Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden |
| Agency | FDA |
| Recall / campaign no. | Lot Code: UDI: SW12300 - 00386270001863 |
WHAT YOU SHOULD DO
- Check if your Dexcom G7 or Dexcom ONE+ app version is 2.8.0 or earlier (or 1.4.0 or earlier for ONE+).
- Update to the latest Dexcom app version as advised by the manufacturer.
- Do not rely solely on the app for critical glucose alerts; monitor glucose levels manually and seek medical guidance if you notice symptoms.
- Contact Dexcom customer support or your healthcare provider for guidance about the recall and safety.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.