Home / Recalls / Dexcom, Inc. / Z-2449-2025

Z-2449-2025 Class I Ongoing

Recalled by Dexcom, Inc. — San Diego, CA

FDA device recall Z-2449-2025 was initiated by Dexcom, Inc. on July 24, 2025 and is designated Class I. 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 an… The recall status is ongoing. Affected quantity: 41629.

Recall Details

Product Type: Devices
Report Date: September 10, 2025
Initiation Date: July 24, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 41629

Product Description

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 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.

Distribution Pattern

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

Code Information

Lot Code: UDI: SW14245 - 00386270004314

Other recalls by Dexcom, Inc.

Z-2574-2026 Class II — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (May 27, 2026)
Z-2163-2026 Class II — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (April 14, 2026)
Z-2165-2026 Class II — Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexc (April 14, 2026)
Z-2164-2026 Class II — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (April 14, 2026)
Z-0318-2026 Class I — Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom (August 28, 2025)
Z-2448-2025 Class I — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (July 24, 2025)
Z-2446-2025 Class I — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (July 24, 2025)
Z-2447-2025 Class I — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (July 24, 2025)
Z-2450-2025 Class I — Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexc (July 24, 2025)
Z-1946-2025 Class I — Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 ( (May 12, 2025)