Dexcom G7 iOS Watch App SW13355Recalls & reported problems
Dexcom, Inc. · G7 iOS Watch App · Class 2
All models of Dexcom G7 (32)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Dexcom G7 iOS watch app has 247 reports on file, with no deaths and 1 injury. Many describe wireless connection problems, the app shutting down unexpectedly, or alarms that did not work, and few describe any patient effects. There are 2 open recalls, both about the app software, with one covering glucose notifications that may queue up and then replay when the app is reopened.
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
- 255
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 255 adverse event reports that list this exact device (DI 00386270005168), received between May 14, 2025 and Sep 23, 2026 — classified as 1 injury, 254 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (108 reports).
2 FDA recall records name this device's identifier, 2 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. 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
- Apr 14, 2026Class IIOpen, Classified
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a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
Z-2164-2026 · Root cause: Software design · Recall details · FDA record ↗
- Jul 24, 2025Class IOpen, 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-2448-2025 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Wireless Communication Problem108
- Unintended Application Program Shut Down83
- Defective Alarm18
- Display or Visual Feedback Problem10
- Application Program Freezes or Fails to Launch9
- Appropriate Device Problem Term/Code Not Available9
- No Audible Alarm7
- Operating System Version or Upgrade Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions254
- Fall1
- Hypoglycemia1
Recent adverse event reports
The 25 most recent of 255 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875454 ↗MalfunctionSep 21, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847768 ↗MalfunctionSep 17, 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 50804508 ↗MalfunctionSep 15, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781770 ↗MalfunctionSep 11, 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 50736036 ↗MalfunctionSep 9, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701962 ↗MalfunctionSep 8, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675575 ↗MalfunctionSep 8, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674794 ↗MalfunctionAug 26, 2026Display or Visual Feedback Problem
It was reported that a display issue occurred on a mobile application. 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 50457630 ↗MalfunctionAug 25, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50439525 ↗MalfunctionAug 13, 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 50244594 ↗MalfunctionAug 11, 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 50204217 ↗MalfunctionAug 11, 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 50201704 ↗MalfunctionAug 7, 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50182868 ↗MalfunctionAug 5, 2026Defective Alarm
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50144802 ↗MalfunctionAug 5, 2026Wireless Communication Problem
It was reported that an unspecified error message occurred. Data was provided for investigation. Confirmation of the complaint was confirmed via data. However, signal loss over an hour was found in connection to the allegation. 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 50143700 ↗MalfunctionAug 4, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50136163 ↗MalfunctionJul 31, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50104444 ↗MalfunctionJul 31, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50103241 ↗MalfunctionJul 29, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50076009 ↗MalfunctionJul 27, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50027039 ↗MalfunctionJul 27, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50015296 ↗MalfunctionJul 27, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50011111 ↗MalfunctionJul 27, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50008711 ↗MalfunctionJul 27, 2026Unintended Application Program Shut Down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50003593 ↗
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-2446-2025 · Jul 24, 2025 · Open, ClassifiedBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product
- 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 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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