BEUDAMED
    FDA Enforcement Class II Ongoing

    IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.

    Recall: Z-2197-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2197-2025
    Event ID
    97146
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LTS Therapy Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 6, 2025
    Initiation Date
    May 22, 2025
    Classification Date
    July 29, 2025
    Address
    1685 Marthaler Ln, Saint Paul, MN, 55118-3517, United States

    Description

    IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.

    Reason

    The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

    Code Info

    Lot Code: UDI-DI: (01) 10815611020012 UDI-PI: (10) 4303 Lot numbers: 4303-1, 4303-2, 4303-3

    Distribution

    US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.

    Quantity

    63936 units