BEUDAMED
    FDA Enforcement Class II Ongoing

    Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface that controls the Omnipod 5 Automated Insulin Delivery System. It is used to activate/deactivate Pods, display alerts/alarms, and send insulin delivery commands for execution to the Pod. Only available in the US.

    Recall: Z-2016-2025 · Reported July 2, 2025

    Enforcement

    Recall Number
    Z-2016-2025
    Event ID
    96945
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Insulet Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 2, 2025
    Initiation Date
    May 23, 2025
    Classification Date
    June 24, 2025
    Address
    50 & 100 Nagog Park, Acton, MA, 01720-3440, United States

    Description

    Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface that controls the Omnipod 5 Automated Insulin Delivery System. It is used to activate/deactivate Pods, display alerts/alarms, and send insulin delivery commands for execution to the Pod. Only available in the US.

    Reason

    Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.

    Code Info

    Model Number: PT-000664/M009-S-AP. UDI-DI: 10385083000336. All software versions 1.X.X

    Distribution

    US market only- Although there are 122823 downloads of the application, our data shows there are only ~80k active users.

    Quantity

    122,823 downloads