LTS Therapy Systems, LLC: Medical Device Recall in 2025 - (Recall #: Z-2197-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 22, 2025

Date Posted: August 6, 2025

Recall Number: Z-2197-2025

Event ID: 97146

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.

Status: Ongoing

Product Quantity: 63936 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated