The Recall Desk
SevereFDA (Devices)·Z-2450-2025·Announced 2025-09-10

Dexcom G7 and ONE+ Glucose Monitoring App Misses Sensor Failure Alert

Dexcom's G7 and ONE+ CGM apps fail to alert users when the sensor fails. Instead of notifying the user, the app silently ends monitoring, potentially delaying treatment of dangerous blood sugar extremes.

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: This is an FDA Class I medical device recall. Although no deaths or illnesses have been reported, the missing alert could prevent timely detection of critical sensor failures, leading to missed detection of life-threatening blood glucose extremes and delayed treatment in diabetic patients.

Plain-English summary

Dexcom, Inc. is recalling Dexcom G7 Continuous Glucose Monitoring (CGM) systems using iOS, watchOS, and Android apps (versions 2.8.0 or earlier) and Dexcom ONE+ CGM systems using iOS and Android apps (versions 1.4.0 or earlier).

The affected apps do not provide a "Sensor Failed" alert when the transmitter detects a hardware or firmware failure. Instead of alerting the user, the app silently ends the glucose monitoring session and displays a "Start Sensor" or "No active sensor" message without notification. This can lead to missed detection of dangerous high or low blood sugar events and delays in necessary treatment.

Users with affected Dexcom G7 or ONE+ systems should update their app to the latest version immediately. Continue monitoring glucose readings carefully and consult the Dexcom website for updated version information. If you have concerns about your device, contact Dexcom or your healthcare provider.

Approximately 39,309 units of the affected app versions have been distributed worldwide.

The recalled product

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
Manufacturer
Dexcom, Inc.
Category
Medical Device — Glucose Monitoring
Hazard
  • missing-alert
  • device-failure
  • missed-detection
  • delayed-treatment

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: SW14244 - 00386270004307

Distribution

Distributed nationwide across the United States.

Related recalls

Same category