FDA Device recall Z-2197-2025
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080 by Lts Therapy Systems, citing the nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2197-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-22 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Lts Therapy Systems |
| Distribution | US |
Product
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The 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.
Identifiers
| code_info | Lot Code: UDI-DI: (01) 10815611020012 UDI-PI: (10) 4303 Lot numbers: 4303-1, 4303-2, 4303-3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2197-2025%22
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