Medical device recalls Moderate risk

LTS Therapy Systems, LLC recalls IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transderma…

Recall date
May 22, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2197-2025
FDA classification
Class II
Brand / firm
LTS Therapy Systems, LLC
Sold / distributed
US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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