Dexcom G6 Receiver STK-FR-001Recalls & reported problems
Dexcom, Inc. · G6 Receiver Kit, Retail - US Falcon · Class 2
All models of Dexcom G6 (13) · Dexcom G6 Receiver (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Dexcom G6 receiver is a display for a glucose monitoring system. Many of the 1,356 reports describe unexpected resets or shutdowns, and some describe alarms that do not sound. The reports include no deaths and 9 injuries. Reports fell from 748 in the prior 12 months to 373 in the latest 12 months. One open recall, starting May 2025, covers a foam or assembly problem that can cause missed audible alerts for low or high blood sugar.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,373
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,373 adverse event reports that list this exact device (DI 00386270003225), received between Nov 21, 2023 and Sep 29, 2026 — classified as 9 injuries, 1,364 malfunctions.
The most frequently reported specific device problem is “Inappropriate or Unexpected Reset” (559 reports).
1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- May 12, 2025Class IOpen, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Inappropriate or Unexpected Reset559
- Unexpected Shutdown277
- No Audible Alarm150
- Defective Alarm127
- Display or Visual Feedback Problem99
- Wireless Communication Problem93
- Unable to Obtain Readings38
- Low Audible Alarm19
Patient problems
- No Clinical Signs, Symptoms or Conditions1,364
- Hypoglycemia7
- Diaphoresis3
- Loss of consciousness3
- Bone Fracture(s)1
- Convulsion/Seizure1
- Hyperglycemia1
- Intracranial Hemorrhage1
Recent adverse event reports
The 25 most recent of 1,373 reports, in the reporter's own words as published by the FDA.
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 25, 2026Appropriate Device Problem Term/Code Not Available
It was reported that an alert/notification settings issue occurred. Data was not investigated on an individual level. The issue will be reviewed at a strategic level on a regular basis. 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 50896014 ↗MalfunctionSep 23, 2026Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874782 ↗MalfunctionSep 22, 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 50860112 ↗MalfunctionSep 22, 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 50858073 ↗MalfunctionSep 22, 2026Wireless Communication Problem
It was reported that a signal loss occurred frequently between 8/24/2026 and 8/26/2026. 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 50855824 ↗MalfunctionSep 21, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846317 ↗MalfunctionSep 18, 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 50819320 ↗MalfunctionSep 18, 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 50817696 ↗MalfunctionSep 16, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793610 ↗MalfunctionSep 16, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793598 ↗MalfunctionSep 15, 2026Wireless Communication Problem
It was reported that a signal loss 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 50778426 ↗MalfunctionSep 14, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763155 ↗MalfunctionSep 10, 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 50718605 ↗MalfunctionSep 10, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717282 ↗MalfunctionSep 2, 2026Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572495 ↗MalfunctionSep 1, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550926 ↗MalfunctionSep 1, 2026No Audible Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50549819 ↗MalfunctionSep 1, 2026Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50544839 ↗MalfunctionAug 28, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50502189 ↗MalfunctionAug 27, 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 50481650 ↗MalfunctionAug 26, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50458052 ↗MalfunctionAug 25, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50435255 ↗MalfunctionAug 14, 2026Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50259388 ↗MalfunctionAug 13, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50245123 ↗
Other Integrated Continuous Glucose Monitoring System, Factory Calibrated devices
- Dexcom G6 Transmitter 9445-24Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated240,475 reports
- Dexcom G6 Transmitter 9445-02Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated3 deaths229,493 reports
- Dexcom G6 Sensor Applicator Assembly 9500-45Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall4 deaths114,678 reports
- US G6 Transmitter (Retail, Receiver Optional) STT-OE-002Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated76,977 reports
- Dexcom G7 GSS (161) 9500-161Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated70,146 reports
- Dexcom G7 iOS App SW12300Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated3 recalls1 death55,219 reports
- Dexcom G7 GSS (161) STP-AT-012Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall5 deaths48,180 reports
- G6 Medicare Transmitter STT-OM-001Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated38,339 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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