The Recall Desk
HighFDA (Devices)·Z-1906-2025·Announced 2025-06-11

Dexcom G7 iOS App version 2.7.0 stops updating glucose readings

Dexcom G7 iOS App version 2.7.0 can enter a state where glucose readings freeze and alerts do not trigger, risking missed detection of dangerously high or low blood sugar. Other connected devices like Apple Watch and insulin pumps continue to receive glucose data directly from the transmitter.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a software product that controls a high-risk medical device. Although no illnesses or injuries are reported in the source text, the hazard—missed detection of severe hypoglycemia or hyperglycemia—poses a direct risk of serious harm to diabetic users. This meets the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Dexcom, Inc. is recalling the Dexcom G7 iOS Application (software version 2.7.0, Reference SW12300) used with the Dexcom G7 Continuous Glucose Monitoring system. A software bug can cause the app to stop updating estimated glucose values (EGV) while continuing to display outdated readings. When this occurs, glucose alerts may not trigger, potentially leading to missed detection of hyperglycemic or hypoglycemic events or treatment decisions based on incorrect data.

The affected app has been distributed worldwide to approximately 61,355 users across the United States and multiple countries including Canada, Australia, the United Kingdom, and others.

The recall does not affect other connected devices. Apple Watch displays, insulin pumps, receivers, and Automated Insulin Dosing (AID) systems will continue to receive glucose data directly from the Dexcom transmitter and will not be impacted by the app's failure to update.

Users who suspect their G7 iOS App is displaying stale glucose readings should contact Dexcom or their healthcare provider for further assistance.

The recalled product

Product
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
Manufacturer
Dexcom, Inc.
Category
Medical Device — Software / Mobile Application
Hazard
  • glucose-reading-failure
  • missed-hypoglycemia-alert
  • missed-hyperglycemia-alert
  • software-bug

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)

  • Software version 2.7.0/ UDI: 00386270001863

Distribution

Distributed nationwide across the United States.

Related recalls

Same category