BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0132-2026
    Event ID
    97597
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Insulet Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 22, 2025
    Initiation Date
    September 11, 2025
    Classification Date
    October 10, 2025
    Address
    50 & 100 Nagog Park, Acton, MA, 01720-3440, United States

    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.

    Code Info

    Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X

    Distribution

    US Nationwide distribution.

    Quantity

    174,013 units