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U.S. Department of Health and Human Services

Class 1 Device Recall Dexcom G6 Continuous Glucose Monitoring System

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 Class 1 Device Recall Dexcom G6 Continuous Glucose Monitoring Systemsee related information
Date Initiated by FirmAugust 28, 2025
Date PostedOctober 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0318-2026
Recall Event ID 97607
510(K)NumberK223931 
Product Classification Integrated Continuous Glucose Monitoring system, factory calibrated - Product Code QBJ
ProductBrand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System
Code Information Lot Code: UDI: SW11678 - 00386270000811
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		A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).
FDA Determined
Cause 2		Software Design Change
ActionOn 09/18/2025, the firm sent via in-app and email an "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION" communication informing customer that a bug has been identified within the G6 Android app version 1.15.0 that can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, or alerts. Customers are instructed to: Upgrading from app version 1.15.0 is mandatory and they will not be able to use app version 1.15.0 after October 6th, 2025. Update your app now to continue using the app: 1. Open the App Store and search for the Dexcom G6 app. 2. Install the latest Dexcom G6 app version. 3. Open the Dexcom G6 app. For questions or further assistance - contact Technical Support at 1-844-478-1600. Technical Support is available 24 hours a day/7 days a week
Quantity in Commerce333
DistributionThis product was distributed throughout the US. G6 Android US v1.15.0 SW11678 G6 and G6 Pro Android app release has been halted <1% rollout after this issue was identified. Please see the attached consignee data for additional details.
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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