BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated May 23, 2025

    Recall

    Recall Number
    Z-2016-2025
    Event Number
    96945
    FEI Number
    3014585508
    Product Code
    QRX
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    May 23, 2025
    Posted
    June 24, 2025
    Address
    Corporation 50, Insulet &, Nagog Park Acton, MA, 01720-3440

    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.

    Action

    Insulet notified health care professionals and users on 05/23/2025 via emailed letter. Consignees were instructed to make sure your phone s keyboard and region settings match the approved country for use currently, the U.S. only and this issue does not affect the Insulet-provided Omnipod 5 Controllers or the Omnipod 5 App on compatible Android phones. A software update will be pushed to all devices in the coming weeks, and each consignee will be notified via email and in-app notification on the device when it is ready to install. The fix will allow commas to be recognized as decimal points when using the Omnipod 5 App for iPhone. The email notification to users included a section to formally acknowledge the notification.

    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