The Recall Desk

FDA (Devices) recall action 97262

Dexcom, Inc. recalled 5 products on 2025-09-10

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2025-09-10
Critical
5
Units
2,429,443

Why these products were recalled

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 scr…

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • CriticalFDA (Devices)··2025-09-10

    Dexcom ONE+ Android app recalled over missing sensor failure alerts

    The Dexcom ONE+ Android CGM App, versions 1.4.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 41,629 units are affected.

    Product
    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ Androind CGM App Component: Dexcom ONE+ Continuous Glucose Monit
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  • CriticalFDA (Devices)··2025-09-10

    Dexcom G7 iOS app recalled because sensor failure alerts do not appear

    The Dexcom G7 CGM iOS App, versions 2.8.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 907,842 units are affected.

    Product
    Brand 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 Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System
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  • CriticalFDA (Devices)··2025-09-10

    Glucose monitor apps recalled because sensor failed alerts do not appear

    Dexcom G7 and ONE+ CGM apps are recalled because the app does not give the expected Sensor Failed alert, instead silently ending the session. The FDA classified the action as Class I. 532,821 units are affected.

    Product
    Brand 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 Description: Dexcom G7 CGM Android App SW12299 Component: Dexcom G7 Continuous Glucose Monitor
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    0 states
  • CriticalFDA (Devices)··2025-09-10

    Dexcom G7 watchOS app recalled because sensor failure alerts are missing

    The Dexcom G7 CGM watchOS App, versions 2.8.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 907,842 units are affected.

    Product
    Brand 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 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone
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    0 states
  • CriticalFDA (Devices)··2025-09-10

    Dexcom ONE+ iOS app recalled because sensor failed alerts do not appear

    The Dexcom ONE+ iOS CGM App, versions 1.4.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 39,309 units are affected.

    Product
    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring Sys
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