Dexcom G7 Android App SW12299Recalls & reported problems
Dexcom, Inc. · G7 Android App · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is the Dexcom G7 Android app. Its reports mostly describe the app shutting down unexpectedly, crashing or freezing, and alarms that do not work. There are 28,198 reports, with no deaths and 39 injuries. One recall, started in July 2025, is open: it covers older app versions. Reports rose to 24,423 in the last 12 months, from 3,212 before.
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
- 28,569
- Deaths reported
- 0
- Injuries reported
- 43
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 28,569 adverse event reports that list this exact device (DI 00386270001870), received between Dec 27, 2022 and Sep 30, 2026 — classified as 43 injuries, 28,524 malfunctions.
The most frequently reported specific device problem is “Protective Measures Problem” (19,435 reports).
1 FDA recall record name this device's identifier, 1 still open.
3 other recalls cover devices cleared under the same FDA submission (K213919); they may or may not involve this specific model.
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
Recalls naming this device
- Jul 24, 2025Open, 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.
Z-2446-2025 · Root cause: Software design · FDA record ↗
Most reported problems
Device problems
- Protective Measures Problem19,435
- Unintended Application Program Shut Down4,570
- Operating System Version or Upgrade Problem1,478
- Application Program Freezes or Fails to Launch909
- Wireless Communication Problem808
- Defective Alarm434
- Display or Visual Feedback Problem416
- No Audible Alarm394
Patient problems
- No Clinical Signs, Symptoms or Conditions28,525
- Hypoglycemia23
- Loss of consciousness13
- Hyperglycemia6
- Hypoglycemic Shock6
- Convulsion/Seizure5
- Headache5
- Shaking/Tremors5
Recent adverse event reports
The 25 most recent of 28,569 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954762 ↗MalfunctionSep 30, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954756 ↗MalfunctionSep 30, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954643 ↗MalfunctionSep 30, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954642 ↗MalfunctionSep 30, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954634 ↗MalfunctionSep 30, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954631 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951951 ↗MalfunctionSep 30, 2026Display or Visual Feedback Problem
It was reported that an alert/notification settings occurred. Performance data was reviewed. The allegation was undetermined via data. However, it was found that EGVs not updating issue occurred within the investigation window. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951434 ↗MalfunctionSep 30, 2026Display or Visual Feedback Problem
It was reported that an alert/notification settings occurred. Performance data was reviewed. The allegation was undetermined via data. However, it was found that EGVs not updating issue occurred within the investigation window. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951135 ↗MalfunctionSep 30, 2026Unintended Application Program Shut Down
It was reported that an alert/notification settings occurred. Performance data was reviewed. The allegation was undetermined via data. However, it was found that an app crash occurred within the investigation window. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951131 ↗MalfunctionSep 30, 2026Wireless Communication Problem
It was reported that signal loss occurred. It was determined that loss of connection was related to the Mobile Application. Performance data was reviewed. The allegation was confirmed due to the finding of signal loss over an hour within the investigation window. The probable cause was the transmitter and app were unable to establish a connection. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949447 ↗MalfunctionSep 30, 2026Unintended Application Program Shut Down
It was reported that an alert/notification settings occurred. Performance data was reviewed. The allegation was undetermined via data. However, it was found that an app crash occurred within the investigation window. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948111 ↗MalfunctionSep 30, 2026Unintended Application Program Shut Down
It was reported that an alert/notification settings occurred. Performance data was reviewed. The allegation was undetermined via data. However, it was found that an app crash occurred within the investigation window. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947308 ↗MalfunctionSep 30, 2026Unintended Application Program Shut Down
It was reported that an alert/notification settings occurred. Performance data was reviewed. The allegation was undetermined via data. However, it was found that an app crash occurred within the investigation window. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943599 ↗MalfunctionSep 30, 2026Defective Alarm
It was reported that no alert/notification occurred. Performance data was reviewed. The allegation was confirmed due to the finding of No Alert/Notification. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943598 ↗MalfunctionSep 29, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941122 ↗InjurySep 29, 2026No Audible Alarm
Patient problems: Hypoglycemia
MAUDE report 50940876 ↗MalfunctionSep 29, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940873 ↗MalfunctionSep 29, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940313 ↗MalfunctionSep 29, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940303 ↗MalfunctionSep 29, 2026Operating System Version or Upgrade Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939742 ↗MalfunctionSep 29, 2026Operating System Version or Upgrade Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939740 ↗MalfunctionSep 29, 2026Operating System Version or Upgrade Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939732 ↗MalfunctionSep 29, 2026Operating System Version or Upgrade Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939022 ↗MalfunctionSep 29, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937255 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K213919. One submission often covers many models, so check the product and lot details in each record.
- Z-2448-2025 · Jul 24, 2025 · Open, ClassifiedBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Produc
- Z-2447-2025 · Jul 24, 2025 · Open, ClassifiedBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Des
- Z-1944-2025 · May 12, 2025 · Open, ClassifiedDexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.