BEUDAMED
    FDA Enforcement Class I Ongoing

    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

    Recall: Z-0318-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0318-2026
    Event ID
    97607
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Dexcom, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2025
    Initiation Date
    August 28, 2025
    Classification Date
    October 30, 2025
    Address
    6340 Sequence Dr, N/A, San Diego, CA, 92121-4356, United States

    Description

    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

    Reason

    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).

    Code Info

    Lot Code: UDI: SW11678 - 00386270000811

    Distribution

    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.

    Quantity

    333