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Dexcom G6 Receiver STK-FM-001Recalls & reported problems

Dexcom, Inc. · G6 Falcon Receiver US Medicare · Class 2

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 the G6 glucose monitor. Its 483 adverse event reports mostly describe unexpected resets and shutdowns, with some mentioning missed alarms. There are no deaths and 2 injuries, and reports fell from 255 in the prior 12 months to 87 in the last 12. There is 1 open recall, started in May 2025, over a foam or assembly problem that may 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
483
Deaths reported
0
Injuries reported
2
Recalls naming it
1

Summary

The FDA's MAUDE database contains 483 adverse event reports that list this exact device (DI 00386270003232), received between Jun 23, 2023 and Sep 14, 2026 — classified as 2 injuries, 481 malfunctions.

The most frequently reported specific device problem is “Inappropriate or Unexpected Reset” (203 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 4 reportsDec 2023: 6 reportsJan 2024: 7 reportsFeb 2024: 6 reportsMar 2024: 8 reportsApr 2024: 14 reportsMay 2024: 12 reportsJun 2024: 16 reportsJul 2024: 13 reportsAug 2024: 19 reportsSep 2024: 14 reportsOct 2024: 16 reportsNov 2024: 24 reportsDec 2024: 18 reportsJan 2025: 22 reportsFeb 2025: 8 reportsMar 2025: 20 reportsApr 2025: 10 reportsMay 2025: 19 reportsJun 2025: 18 reportsJul 2025: 22 reportsAug 2025: 50 reportsSep 2025: 20 reportsOct 2025: 24 reportsNov 2025: 14 reportsDec 2025: 17 reportsJan 2026: 10 reportsFeb 2026: 18 reportsMar 2026: 5 reportsApr 2026: 6 reportsMay 2026: 6 reportsJun 2026: 5 reportsJul 2026: 5 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports20242025202650
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. 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 · FDA record ↗

Most reported problems

Device problems

  • Inappropriate or Unexpected Reset203
  • Unexpected Shutdown84
  • Defective Alarm52
  • No Audible Alarm40
  • Display or Visual Feedback Problem35
  • Wireless Communication Problem32
  • Low Audible Alarm15
  • Unable to Obtain Readings15

Patient problems

  • No Clinical Signs, Symptoms or Conditions480
  • Diaphoresis2
  • Hypoglycemia2
  • Convulsion/Seizure1
  • High Blood Pressure/ Hypertension1
  • Loss of consciousness1

Recent adverse event reports

The 25 most recent of 483 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 14, 2026Inappropriate or Unexpected Reset

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50765454 ↗
  • MalfunctionJul 27, 2026Inappropriate or Unexpected Reset

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50012777 ↗
  • MalfunctionJul 27, 2026Unexpected Shutdown

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50001257 ↗
  • MalfunctionJul 15, 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 25827788 ↗
  • MalfunctionJul 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 25787447 ↗
  • MalfunctionJul 10, 2026Inappropriate or Unexpected Reset

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25782069 ↗
  • MalfunctionJun 25, 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 25629750 ↗
  • MalfunctionJun 16, 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 25521850 ↗
  • MalfunctionJun 5, 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 25414988 ↗
  • MalfunctionJun 5, 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 25413214 ↗
  • MalfunctionJun 5, 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 25410714 ↗
  • MalfunctionMay 28, 2026Defective Alarm

    IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE 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 25319433 ↗
  • MalfunctionMay 28, 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 25318598 ↗
  • MalfunctionMay 20, 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 25231896 ↗
  • MalfunctionMay 5, 2026Inappropriate or Unexpected Reset

    AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 6/2/2026 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25088576 ↗
  • MalfunctionMay 5, 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 25086104 ↗
  • MalfunctionMay 1, 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 25059037 ↗
  • MalfunctionApr 27, 2026Wireless Communication Problem

    IT WAS REPORTED THAT "SIGNAL LOSS" OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND THE PROBABLE CAUSE CANNOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25001214 ↗
  • MalfunctionApr 23, 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 24975003 ↗
  • MalfunctionApr 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 24956358 ↗
  • MalfunctionApr 21, 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 24942838 ↗
  • MalfunctionApr 13, 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 24866300 ↗
  • MalfunctionApr 2, 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 24769009 ↗
  • MalfunctionMar 26, 2026Inappropriate or Unexpected Reset

    AFTER SUBMISSION OF THE INITIAL MDR PRODUCT WAS RECEIVED ON 4/20/2026. IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24702490 ↗
  • MalfunctionMar 12, 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 24581314 ↗

Other Integrated Continuous Glucose Monitoring System, Factory Calibrated devices

All Integrated Continuous Glucose Monitoring System, Factory Calibrated devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.