Dexcom Recalls G6 Android App Over Software Failure Risks

Dexcom has initiated a Class 1 recall—the FDA’s most serious category—for its G6 continuous glucose monitor (CGM) Android app due to a software issue that could cause the app to crash unexpectedly. The malfunction may prevent users from receiving critical glucose alerts and alarms, potentially leading to missed hyperglycemia or hypoglycemia events, including diabetic ketoacidosis. The recall, which began on August 28, affects version 1.15 of the app.

Dexcom notified affected users in September, instructing them to update to a fixed version. The company reported that the issue was identified before widespread release, impacting only 333 users, all of whom have now updated to a safe version.

This marks Dexcom’s third Class 1 recall in 2025, following earlier actions involving its G7 sensors and CGM receivers, both related to alert and notification failures that could compromise patient safety.

11-11-2025