LTS Therapy Systems, LLC: Device Recall
Recall #Z-2196-2025 · 05/22/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2196-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- LTS Therapy Systems, LLC
- Status
- Ongoing
- Date Initiated
- 05/22/2025
- Location
- Saint Paul, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80928 units
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.
Product Description
IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
Distribution Pattern
US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.
Other Recalls by LTS Therapy Systems, LLC
- Class II: Risk 05/22/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.