Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Recalled by Dexcom, Inc. Due to A software defect in version v1.15.0 of the...

Date: August 28, 2025
Company: Dexcom, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Dexcom, Inc. directly.

Affected Products

Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System

Quantity: 333

Why Was This Recalled?

A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).

Where Was This Sold?

This product was distributed throughout the US. G6 Android US v1.15.0 SW11678 G6 and G6 Pro Android app release has been halted <1% rollout after this issue was identified. Please see the attached consignee data for additional details.

About Dexcom, Inc.

Dexcom, Inc. has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report