Recall Z-2449-2025— Dexcom, Inc.

Class I FDA medical device recall by Dexcom, Inc., initiated 2025-07-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ Androind CGM App Component: Dexcom ONE+ 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..

Recalling firm

Dexcom, Inc.

Classification

Class I

Status

Ongoing

Initiated

2025-07-24

Firm location

San Diego, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.