BEUDAMED
    FDA Recall Open, Classified

    The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.

    Recall: Z-0132-2026 · Initiated September 11, 2025

    Recall

    Recall Number
    Z-0132-2026
    Event Number
    97597
    FEI Number
    3014585508
    Product Code
    QRX
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 11, 2025
    Posted
    October 10, 2025
    Address
    Corporation 50, Insulet &, Nagog Park Acton, MA, 01720-3440

    Description

    The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.

    Reason

    The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.

    Action

    Insulet notified both healthcare professionals and users on about 09/11/2025 via URGENT: Medical Device Correction letter. Instructions included that an update to the application will be pushed to all devices and should be implemented by users. Users were also requested to confirm receipt and acknowledgement of the notification but selecting the "acknowledgement button" in the email.

    Distribution

    US Nationwide distribution.

    Quantity

    174,013 units