IontoPatch STAT — Class II medical device recall Z-2196-2025
Ongoing recall by LTS Therapy Systems, LLC, reported 2025-08-06, distributed nationwide. The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with
| Recall number | Z-2196-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LTS Therapy Systems, LLC, Saint Paul, MN, United States |
| Recall initiated | 2025-05-22 |
| Classified | 2025-07-29 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 80,928 units |
| UPC / GTIN / UDI-DI | 10815611020005 |
| Lot numbers | 4283, 4283-1, 4283-2, 4283-3, 4283-4 |
| Model numbers | D-0062-080 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2196-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.