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

FDA Recall #Z-2197-2025 — Class II — May 22, 2025

Recall #Z-2197-2025 Date: May 22, 2025 Classification: Class II Status: Ongoing

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.

Recalling Firm

LTS Therapy Systems, LLC — Saint Paul, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

63936 units

Distribution

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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