Home / Recalls / LTS Therapy Systems, LLC / Z-2197-2025

Z-2197-2025 Class II Ongoing

Recalled by LTS Therapy Systems, LLC — Saint Paul, MN

Recall Details

Product Type: Devices
Report Date: August 6, 2025
Initiation Date: May 22, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 63936 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

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