Dexcom, Inc.: 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

Recall number

Z-2447-2025

Recalling firm

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

Status

Open, Classified

Initiated

2025-07-24

Posted

2025-09-04

Terminated

not on file

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.

Root cause

Software design

Action

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

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, 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

Lot, serial or model codes

Lot Code: UDI: SW12300 - 00386270001863

510(k) numbers

["K213919"]

PMA numbers

not on file

Product code

QBJ

Firm FEI

3004753838

Firm city

San Diego

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy