Recall Z-2196-2025— LTS Therapy Systems, LLC

Name: FDA recall Z-2196-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-22

Class II · Ongoing

Class II FDA medical device recall by LTS Therapy Systems, LLC, initiated 2025-05-22. It names one FDA 510(k) clearance: K992708. Product: IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; 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..

Recalling firm: LTS Therapy Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-05-22
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K992708 — IONTOPATCHBirch Point Medical, Inc.·cleared 2000-02-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.