FDA Device recall Z-1204-2025
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001
- FDA Device
- Class II
- ongoing
- Published 2025-02-26
On 2025-02-26 the FDA classified a Class II recall of Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001 by Dexcom, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1204-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-27 |
| Published | 2025-02-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Dexcom |
| Distribution | US |
Product
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001
Reason
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 triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.
Identifiers
| code_info | All Serial Numbers/UDI: 00386270001900 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1204-2025%22
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