Dexcom G6Recalls & reported problems across all models
Dexcom, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
5 open recalls name at least one Dexcom G6 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 637,302
- Deaths reported
- 8
- Injuries reported
- 5,207
- Recalls
- 7
We found 13 models of Dexcom G6 by Dexcom, Inc. in the FDA's device registry (GUDID). Together they are named in 637,302 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2017 and Sep 30, 2026 — classified as 8 deaths, 5,207 injuries, 632,087 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (292,521 reports).
7 FDA recall records name at least one of these models by its device identifier, 5 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Dexcom G6 recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 28, 2025Open, 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).
Z-0318-2026 · Root cause: Software Design Change · Recall details · FDA record ↗
- May 12, 2025Open, 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.
Z-1943-2025 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗
- Jan 27, 2025Open, 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.
Z-1204-2025 · Root cause: Software design · Recall details · FDA record ↗
- Jan 27, 2025Open, 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.
Z-1203-2025 · Root cause: Software design · Recall details · FDA record ↗
- Jan 27, 2025Open, 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.
Z-1202-2025 · Root cause: Software design · Recall details · FDA record ↗
- Feb 3, 2020Terminated
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.
Z-1562-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 19, 2019Terminated
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.
Z-1104-2020 · Root cause: Software design · Recall details · FDA record ↗
Most reported Dexcom G6 problems
Device problems
- Wireless Communication Problem292,521
- No Device Output180,230
- Imprecision42,021
- Premature End-of-Life Indicator34,477
- Incorrect, Inadequate or Imprecise Result or Readings19,327
- Detachment of Device or Device Component10,340
- Appropriate Device Problem Term/Code Not Available10,228
- Unintended Application Program Shut Down6,310
Patient problems
- No Clinical Signs, Symptoms or Conditions383,475
- No Consequences Or Impact To Patient221,902
- Hyperglycemia27,310
- Hypoglycemia5,593
- Loss of consciousness1,263
- Foreign Body In Patient1,097
- Dizziness802
- Fatigue651
Dexcom G6 models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Dexcom G6 Transmitter 9445-24Integrated Continuous Glucose Monitoring System, Factory Calibrated240,475 reports
- Dexcom G6 Transmitter 9445-02Integrated Continuous Glucose Monitoring System, Factory Calibrated3 deaths229,493 reports
- Dexcom G6 Sensor Applicator Assembly 9500-45Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall4 deaths114,678 reports
- Dexcom G6 iOS SW11677Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall23,526 reports
- Dexcom G6 Receiver MT24078Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall15,819 reports
- Dexcom G6 Android SW11678Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall1 death4,055 reports
- Dexcom G6 Receiver STK-OE-001Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall2,845 reports
- Dexcom G6 Sensor Kit (1) Medicare STS-OM-001Integrated Continuous Glucose Monitoring System, Factory Calibrated2,371 reports
- Dexcom G6 Receiver Kit STK-OR-001Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall1,969 reports
- Dexcom G6 Receiver STK-FR-001Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall1,373 reports
- Dexcom G6 Receiver STK-FM-001Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall483 reports
- Dexcom G6 Receiver STK-FE-001Integrated Continuous Glucose Monitoring System, Factory Calibrated191 reports
- Dexcom G6 Professional System STP-PR-001Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use24 reports
Recent Dexcom G6 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954750 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 50949807 ↗MalfunctionSep 30, 2026High Readings
It was reported that an inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred. The sensor was inserted into an off-label insertion site on (b)(6) 2026. Data was evaluated and the allegation was confirmed. The probable cause could not be determined via data. The reported glucose values fall within the D zone of the Parkes Error Grid. The data investigation found a difference in values that fall within the B zone of the Parkes Error Grid. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949497 ↗MalfunctionSep 30, 2026Break
It was reported that an unexpected receiver shutdown occurred. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948827 ↗MalfunctionSep 29, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940995 ↗MalfunctionSep 29, 2026Low Readings
Patient problems: Hyperglycemia
MAUDE report 50940375 ↗MalfunctionSep 29, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938748 ↗MalfunctionSep 29, 2026Unexpected Shutdown
It was reported that an unexpected receiver shutdown occurred. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936265 ↗MalfunctionSep 29, 2026Inappropriate or Unexpected Reset
It was reported that a receiver reinitialization occurred. Data was received but not investigated as data will not confirm the issue. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935535 ↗MalfunctionSep 29, 2026Inappropriate or Unexpected Reset
It was reported that a receiver reinitialization occurred. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932477 ↗MalfunctionSep 28, 2026Low Readings
Patient problems: Hyperglycemia
MAUDE report 50926187 ↗MalfunctionSep 28, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926155 ↗MalfunctionSep 28, 2026Unintended Application Program Shut Down
It was reported that a Dexcom App Crash occurred. Data was evaluated and the allegation was confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923370 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. The sensor was inserted into an off-label insertion site, on (b)(6) 2026. It was indicated that the patient removed the transmitter from the sensor pod before removing the sensor from the body, which is misuse of the device. Data was received but not investigated as data will not confirm the issue. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917775 ↗MalfunctionSep 26, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906373 ↗
Other Dexcom, Inc. products
- Dexcom G6 Transmitter2 models · 469,968 reports
- Dexcom G732 models · 325,909 reports · 8 recalls
- Dexcom G521 models · 206,314 reports · 1 recall
- Dexcom G7 GSS (161)4 models · 141,244 reports · 1 recall
- Dexcom G4 Platinum41 models · 119,308 reports · 2 recalls
- Dexcom G7 Receiver4 models · 33,732 reports · 1 recall
- Dexcom G7 GSS (160)4 models · 33,558 reports
- Dexcom G5 Mobile Receiver3 models · 26,327 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered, combining the brand names used for this product line.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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