Recall Z-0318-2026 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Dexcom, Inc.
Brand 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
| Date | Oct 30, 2025 (initiated Aug 28, 2025) |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | Software Design Change |
| Action | On 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 |
| Quantity | 333 |
| Distribution | This 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System Dexcom, Inc., Jan 11, 2023 |