Reported Sep 10, 2025 · Ongoing
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog…
Dexcom, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dexcom, Inc. · 6340 Sequence Dr · San Diego, CA · 92121-4356
Is this the product you have?
- Brand NameDexcom G7 Continuous
- Glucose Monitoring System Product NameDexcom
- G7 CGM watchOS App Model/Catalog NumberSW13355
- Software Versionversions 2.8.0
- and earlier Product DescriptionDexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used of each are the same for each user. The watchOS app cannot be installed independently
- from the iOS phone app ComponentDexcom G7 CGM iOS App
- Lot codes and dates
- Lot CodeUDI - SW1355- 00386270005168
- Amount recalled
- 907842
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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