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Dexcom, Inc. · Continuous glucose monitors · Model family Dexcom G6
A real-time continuous glucose monitoring system with a wearable sensor, transmitter, compatible receiver, and mobile apps.
3 ongoing recall records reference this device, out of 3 total records tracked.
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…
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to…
Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be…
| Model | Description | Lot / serial range | Manufactured | Status |
|---|---|---|---|---|
| Z-0318-2026 · SW11678 · version 1.15.0 | Dexcom G6 and G6 Pro Android US CGM App | Lot Code: UDI: SW11678 - 00386270000811 | Not provided in the normalized record | Ongoing |
| Z-1946-2025 | Z-1946-2025 | All Lots/ UDI: STK-DO-006 -00386270003188 STK-DO-013 -00386270002327 STK-DO-103-00386270002969 STK-DO-109 -00386270002792 | Not provided in the normalized record | Ongoing |
| Z-1945-2025 | Z-1945-2025 | All Lots/ UDI: STK-D7-013 - 00386270003812; STK-D7-014 - 00386270003843; STK-D7-103 - 00386270003836 | Not provided in the normalized record | Ongoing |
| Z-1944-2025 | Z-1944-2025 | All Lots/ UDI: STK-AT-011 - 00386270002198 STK-AT-012 -00386270002518 STK-AT-013 - 00386270002525 STK-GT-001 - 00386270004291 STK-GT-008 - 00386270004260 STK-GT-013 - 00386270002273 STK-GT-019 - 04595986293080 STK-GT-100 - 00386270002020 STK-GT-109 - 00386270002129 STK-GT-113 - 00386270003638 | Not provided in the normalized record | Ongoing |
| Z-1943-2025 | Z-1943-2025 | All Lots/ UDI: STK-FM-001 - 00386270003232 & STK-FR-001 - 00386270003225 | Not provided in the normalized record | Ongoing |
| Z-1204-2025 | Z-1204-2025 | All Serial Numbers/UDI: 00386270001900 | Not provided in the normalized record | Ongoing |
| Z-1203-2025 | Z-1203-2025 | All Serial Numbers/UDI: 00386270000590 | Not provided in the normalized record | Ongoing |
| Z-1202-2025 | Z-1202-2025 | All Serial Numbers/UDI: 00386270000583 | Not provided in the normalized record | Ongoing |
Product codes: QBJ, QII