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Sign in to claim this brandDexcom
United States·US-MF-000010694
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 6340, Sequence Dr, San Diego, United States
- Website
- www.dexcom.com
- —
- —
- [email protected]
- Phone
- 1-888-738-3646
- PRRC Contact
- Rishi Jain
- EUDAMED SRN
- US-MF-000010694
- FDA FEI Number
- 3004753838
- DUNS Number
- —
Catalogue (188)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dexcom Flex CGM System | STE-DF-001 | EUDAMED | Class IIb | Active |
| Dexcom Flex CGM System | SW14684 | EUDAMED | Class IIb | Active |
| Dexcom Flex CGM System | SW14682 | EUDAMED | Class IIb | Active |
| Dexcom ONE+ CGM System | SW10920 | EUDAMED | Class IIb | Active |
| Dexcom Flex CGM System | STK-DF-013 | EUDAMED | Class IIb | Active |
| Stelo Glucose Biosensor System | K261359 | FDA 510(k) | Class II | Active |
| US G6 Transmitter | STT-OR-001 | FDA UDI | Class II | Active |
| Dexcom G7 iOS Watch App | SW13355 | FDA UDI | Class II | Active |
| Dexcom G4 PLATINUM Receiver with Share Kit US | STK-DR-PNK | FDA UDI | Class III | Unknown |
| Dexcom G4 PLATINUM Receiver with Share Kit (Retail) US | STK-RR-BLU | FDA UDI | Class III | Unknown |
| Dexcom G7 GSS (151) | STP-AT-011 | FDA UDI | Class II | Active |
| Dexcom G7 GSS (160) | STP-AT-012 | FDA UDI | Class II | Active |
| Dexcom G7 Overpatch 10 Pack | MT-1000392 | FDA UDI | Class I | Active |
| Dexcom G7 GSS (161) | STP-AT-012 | FDA UDI | Class II | Active |
| Dexcom Discovery Transmitter | 9445-19 | FDA UDI | Class II | Active |
| Stelo Glucose Biosensor (2pk) | STP-XN-002 | FDA UDI | Class II | Active |
| Dexcom G5 Mobile Receiver Kit (Retail) | STK-RF-BLU | FDA UDI | Class III | Unknown |
| Dexcom G7 Receiver | MT26403-0 | FDA UDI | Class II | Active |
| Dexcom G6 Receiver | MT24078 | FDA UDI | Class II | Active |
| Dexcom G5 Mobile Receiver | MT22719-BLU | FDA UDI | Class III | Unknown |
| Dexcom G7 GSS (161) | STP-AT-013 | FDA UDI | Class II | Active |
| Dexcom G4 PLATINUM (Pediatric) Receiver with Share Kit US | STK-PR-BLU | FDA UDI | Class III | Unknown |
| Dexcom G6 Android | SW11678 | FDA UDI | Class II | Active |
| Stelo Glucose Biosensor (2pk) | STP-XN-003 | FDA UDI | Class II | Active |
| Dexcom G5 Mobile Receiver Kit | STK-GF-BLU | FDA UDI | Class III | Unknown |
| Dexcom G5 Mobile Receiver Kit | STK-GF-001 | FDA UDI | Class III | Unknown |
| Dexcom Receiver Kit | STK-SD-001 | FDA UDI | Class III | Unknown |
| Dexcom G4 Platinum Transmitter (Retail) US | STT-RX-001 | FDA UDI | Class III | Unknown |
| Dexcom G7 Sample Pack | STE-AT-030 | FDA UDI | Class II | Active |
| Dexcom G6 Transmitter | 9445-02 | FDA UDI | Class II | Unknown |
| Dexcom G6 Receiver Kit | STK-OR-001 | FDA UDI | Class II | Active |
| Dexcom Receiver Kit (Medicare) | STK-MD-001 | FDA UDI | Class III | Active |
| Dexcom G5 Mobile Replacement Receiver Kit | STR-GF-PNK | FDA UDI | Class III | Unknown |
| Dexcom G4 Platinum Professional Receiver Kit | STK-PU-001 | FDA UDI | Class III | Unknown |
| G6 Medicare Transmitter | STT-OM-001 | FDA UDI | Class II | Active |
| Dexcom G7 GSS (161) | 9500-161 | FDA UDI | Class II | Active |
| Dexcom G4 Platinum Receiver Kit (Retail) | STK-RX-001 | FDA UDI | Class III | Unknown |
| Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | STP-FT-012 | FDA UDI | Class II | Active |
| Dexcom Stelo Android Mobile App | SW14117 | FDA UDI | Class II | Active |
| Dexcom G4 Platinum Transmitter Kit US | STT-GL-003 | FDA UDI | Class III | Unknown |
| Dexcom G4 Platinum Receiver | STK-GL-BLU | FDA UDI | Class III | Unknown |
| Dexcom G5 Transmitter | 9438-06 | FDA UDI | Class III | Active |
| Dexcom G7 Sample Pack (161) | STE-AT-030 | FDA UDI | Class II | Active |
| Dexcom G4 Platinum Replacement Receiver Kit | STR-GL-001 | FDA UDI | Class III | Unknown |
| Dexcom G4 Platinum (Pedicatric) Receiver Kit (Retail) | STK-KX-001 | FDA UDI | Class III | Unknown |
| Dexcom G4 Professional Receiver Shield Pack | MT22428 | FDA UDI | Class III | Unknown |
| Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | STP-FT-013 | FDA UDI | Class II | Active |
| Dexcom G7 Receiver | STK-AT-011 | FDA UDI | Class II | Active |
| Dexcom G5 Mobile Receiver | MT22719 | FDA UDI | Class III | Unknown |
| Dexcom Stelo iOS Mobile App | SW14116 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (28)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 14, 2026 | Z-2165-2026 | — | open, classified | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information. |
| Apr 14, 2026 | Z-2164-2026 | — | open, classified | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information. |
| Apr 14, 2026 | Z-2163-2026 | — | open, classified | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information. |
| Aug 28, 2025 | Z-0318-2026 | — | open, classified | 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). |
| Jul 24, 2025 | Z-2447-2025 | — | open, classified | 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. |
| Jul 24, 2025 | Z-2446-2025 | — | open, classified | 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. |
| Jul 24, 2025 | Z-2449-2025 | — | open, classified | 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. |
| Jul 24, 2025 | Z-2450-2025 | — | open, classified | 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. |
| Jul 24, 2025 | Z-2448-2025 | — | open, classified | 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. |
| May 12, 2025 | Z-1946-2025 | — | open, classified | 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 untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death. |
| May 12, 2025 | Z-1943-2025 | — | open, classified | 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 untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death. |
| May 12, 2025 | Z-1944-2025 | — | open, classified | 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 untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death. |
| May 12, 2025 | Z-1945-2025 | — | open, classified | 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 untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death. |
| May 5, 2025 | Z-1906-2025 | — | open, classified | A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter. |
| Jan 27, 2025 | Z-1203-2025 | — | open, classified | 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. |
| Jan 27, 2025 | Z-1204-2025 | — | open, classified | 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. |
| Jan 27, 2025 | Z-1202-2025 | — | open, classified | 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. |
| Feb 3, 2020 | Z-1562-2020 | — | terminated | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems. |
| Feb 3, 2020 | Z-1560-2020 | — | terminated | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems. |
| Feb 3, 2020 | Z-1561-2020 | — | terminated | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems. |
| Nov 19, 2019 | Z-1104-2020 | — | terminated | It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application. |
| Jul 12, 2019 | Z-0929-2020 | — | terminated | It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitialization of the receiver without user interaction. If this occurs, the receiver will either reboot and operate normally or require the user to press the Select button on the receiver in order to resume normal operation. In this situation, the user is provided an audio and vibratory alert every 5 minutes. Until the select button is pressed, patients will not receive glucose values or alerts. |
| Feb 23, 2016 | Z-1339-2016 | — | terminated | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. |
| Feb 23, 2016 | Z-1337-2016 | — | terminated | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. |
| Feb 23, 2016 | Z-1338-2016 | — | terminated | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. |
| Feb 23, 2016 | Z-1334-2016 | — | terminated | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. |
| Feb 23, 2016 | Z-1336-2016 | — | terminated | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. |
| Feb 23, 2016 | Z-1335-2016 | — | terminated | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. |