The Recall Desk
SevereFDA (Devices)·Z-2447-2025·Announced 2025-09-10

Dexcom G7 and ONE+ CGM apps recalled over missed sensor failure alerts

Dexcom G7 and ONE+ CGM mobile apps fail to alert users of critical sensor failures, which may cause missed detection of dangerous blood sugar events and delayed treatment.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I medical device recall. No reported deaths, hospitalizations, or serious injuries documented in the source text. However, the defect affects a life-critical glucose monitoring device and can delay detection and treatment of dangerous blood sugar events.

Plain-English summary

The recalled devices are Dexcom G7 Continuous Glucose Monitoring System mobile apps (iOS and Android versions 2.8.0 and earlier) and Dexcom ONE+ CGM System mobile apps (iOS and Android versions 1.4.0 and earlier). These apps are designed to continuously monitor blood glucose levels and alert users to dangerously high or low blood sugar events.

When a transmitter experiences a hardware or firmware failure, it sends a 'transmitterFailed' error message to the app. The affected app versions do not provide the expected 'Sensor Failed' alert. Instead, the app silently ends the sensor session, stops reporting glucose readings, and displays a 'Start Sensor' or 'No active sensor' message without alerting the user.

This defect can result in users missing the detection of hyperglycemic (dangerously high) or hypoglycemic (dangerously low) blood sugar events, potentially delaying critical medical treatment. The affected apps are distributed worldwide, including throughout the United States.

Users should immediately update their Dexcom G7 or ONE+ app to the latest version available in their device's app store. If you have questions or concerns, contact Dexcom support.

The recalled product

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
Manufacturer
Dexcom, Inc.
Category
Medical Device — Continuous Glucose Monitor
Hazard
  • missed-alert
  • software-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Code: UDI: SW12300 - 00386270001863

Distribution

Distributed nationwide across the United States.

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