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U.S. Department of Health and Human Services

Class 1 Device Recall Dexcom G7 Continuous Glucose Monitoring System

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 Class 1 Device Recall Dexcom G7 Continuous Glucose Monitoring Systemsee related information
Date Initiated by FirmJuly 24, 2025
Date PostedSeptember 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2448-2025
Recall Event ID 97262
510(K)NumberK213919 
Product Classification Integrated Continuous Glucose Monitoring system, factory calibrated - Product Code QBJ
ProductBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Product Description: Dexcom 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 Component: Dexcom G7 CGM iOS App
Code Information Lot Code: UDI - SW1355- 00386270005168
Recalling Firm/
Manufacturer		 Dexcom, Inc.
6340 Sequence Dr
San Diego CA 92121-4356
For Additional Information ContactTim Peterson
1-858-5294548
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 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 in Commerce907842
DistributionSW12299 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QBJ
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