Device recall
Z-2197-2025: IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The…
FDA device recall · Class II · LTS Therapy Systems, LLC
Key facts
| Recall number (Z-number) | Z-2197-2025 |
|---|---|
| Recall event | 97146 |
| Product | IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch. |
| Product code | EGJ |
| Recalling firm | LTS Therapy Systems, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K992708 |
| FEI number | 2182681 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database