The Recall Desk
SevereFDA (Devices)·Z-2446-2025·Announced 2025-09-10

Dexcom G7 and ONE+ apps fail to alert of sensor failures

Dexcom G7 and ONE+ continuous glucose monitoring apps may fail to alert users of sensor failures, potentially delaying treatment of dangerous blood sugar events. Affected Android, iOS, and watchOS versions can silently stop reporting readings without notifying the user.

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 classification applies a minimum severity floor of 4 per rubric. The software defect causes silent sensor failure that can delay detection and treatment of life-threatening glucose abnormalities, though no illnesses or deaths have been reported in the source.

Plain-English summary

Dexcom, Inc. has recalled the Dexcom G7 Continuous Glucose Monitoring System (CGM) apps for Android, iOS, and watchOS (version 2.8.0 and earlier) and Dexcom ONE+ CGM apps for Android and iOS (version 1.4.0 and earlier). These monitoring apps are distributed worldwide.

The apps contain a software defect: when the transmitter detects a hardware or firmware failure and sends a "transmitterFailed" error message, the app fails to display the expected "Sensor Failed" alert. Instead, the app silently ends the sensor session, stops reporting glucose values, and displays generic messages such as "Start Sensor" or "No active sensor" without alerting the user.

As a result, users may not realize their CGM is no longer functioning and may miss detection of critical hyperglycemic (high blood sugar) or hypoglycemic (low blood sugar) events. Missing these alerts can delay medical treatment of dangerous glucose abnormalities.

Approximately 532,821 affected units have been distributed worldwide. The FDA classifies this as a Class I recall.

The recalled product

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
Manufacturer
Dexcom, Inc.
Category
Medical Device — Continuous Glucose Monitoring
Hazard
  • alert-failure
  • hypoglycemia-risk
  • hyperglycemia-risk

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: SW12299 - 00386270001870

Distribution

Distributed nationwide across the United States.

Related recalls

Same category