Class II — LTS Therapy Systems, LLC
| Recalling firm | LTS Therapy Systems, LLC |
|---|---|
| Registered facility | LTS Therapy Systems, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device. |
| Product | IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch. |
| Quantity | 80928 units |
| Distribution | US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota. |
| Initiated | 2025-05-22 |
| Classified | 2025-07-29 |
| Recall number | Z-2196-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — LTS Therapy Systems, LLC (Z-2196-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97146/
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