Dexcom
Active in EUDAMEDAlso registered as Dexcom, Inc.
United Statesfrom SRN EUDAMED FDA SRN US-MF-000010694 FEI 3004753838
- Devices
- 213
- Registrations
- EUDAMEDFDA
- FDA recalls
- 2918 ongoing
What Dexcom makes
The company manufactures continuous glucose monitoring (CGM) systems, including percutaneous interstitial fluid glucose sensors, transmitters, and companion software for real-time glucose tracking. Products include disposable sensor systems like the Dexcom Flex and ONE+ CGM, as well as standalone biosensor systems such as the Stelo. Additional offerings include transmitter units, sensor replacement packs, and mobile app integrations for data display.
The portfolio includes devices classified as Class I, Class II, Class IIb, and Class III under regulatory frameworks. Products are listed in the EU’s eudamed registry, the FDA’s 510(k) and UDI databases, and the company is based in the United States.
Catalogue
Search and filter all 213 devicesShowing 201-213 of 213
Company details
- EUDAMED SRN
- US-MF-000010694
- FDA FEI number
- 3004753838
- EUDAMED status
- Active since 2024
- EUDAMED registered name
- Dexcom
- EUDAMED abbreviated name
- Dexcom
- Registered address
- 6340, Sequence Dr, 92121, San Diego, United States
- Website
- www.dexcom.com
- Phone
- 1-888-738-3646
- PRRC contact
- Rishi Jain
FDA recalls
FDA recall records list 29 recalls initiated by Dexcom, the earliest on 2016-02-23 and the most recent on 2026-05-27. By recorded status: 18 ongoing and 11 terminated. The reasons filed fall into these groups: software or firmware, electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 2
- 2020 3
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 14
- 2026 4
2026
- 27 May 2026 Z-2574-2026 Class II Ongoing Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.
Full distribution text
- 14 Apr 2026 Z-2163-2026 Class II Ongoing 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.
Full distribution text
- 14 Apr 2026 Z-2164-2026 Class II Ongoing 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.
Full distribution text
- 14 Apr 2026 Z-2165-2026 Class II Ongoing 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.
Full distribution text
- 27 May 2026 Z-2574-2026 Class II Ongoing Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.
2025
- 28 Aug 2025 Z-0318-2026 Class I Ongoing 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).
Full distribution text
- 24 Jul 2025 Z-2446-2025 Class I Ongoing 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.
Full distribution text
- 24 Jul 2025 Z-2447-2025 Class I Ongoing 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.
Full distribution text
- 24 Jul 2025 Z-2448-2025 Class I Ongoing 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.
Full distribution text
- 24 Jul 2025 Z-2449-2025 Class I Ongoing 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.
Full distribution text
- 24 Jul 2025 Z-2450-2025 Class I Ongoing 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.
Full distribution text
- 28 Aug 2025 Z-0318-2026 Class I Ongoing 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).
Show the 25 most recent of 29 recalls
2025
- 12 May 2025 Z-1943-2025 Class I Ongoing 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.
Full distribution text
- 12 May 2025 Z-1944-2025 Class I Ongoing 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.
Full distribution text
- 12 May 2025 Z-1945-2025 Class I Ongoing 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.
Full distribution text
- 12 May 2025 Z-1946-2025 Class I Ongoing 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.
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- 5 May 2025 Z-1906-2025 Class II Ongoing 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.
Full distribution text
- 27 Jan 2025 Z-1202-2025 Class II Ongoing 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.
Full distribution text
- 27 Jan 2025 Z-1203-2025 Class II Ongoing 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.
Full distribution text
- 27 Jan 2025 Z-1204-2025 Class II Ongoing 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.
Full distribution text
- 12 May 2025 Z-1943-2025 Class I Ongoing 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.
2020
- 3 Feb 2020 Z-1560-2020 Class II 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.
- 3 Feb 2020 Z-1561-2020 Class II 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.
- 3 Feb 2020 Z-1562-2020 Class II 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.
2019
- 19 Nov 2019 Z-1104-2020 Class II 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.
Full distribution text
- 12 Jul 2019 Z-0929-2020 Class II 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.
- 19 Nov 2019 Z-1104-2020 Class II 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.
2016
- 23 Feb 2016 Z-1334-2016 Class I Terminated Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Full distribution text
- 23 Feb 2016 Z-1335-2016 Class I Terminated Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Full distribution text
- 23 Feb 2016 Z-1334-2016 Class I Terminated Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.