Recall Z-2197-2025 ยท EGJ Device, Iontophoresis, Other Uses
LTS Therapy Systems, LLC
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
| Date | Jul 29, 2025 (initiated May 22, 2025) |
| Status | Open, Classified |
| Reason | The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device. |
| Root cause | Under Investigation by firm |
| Action | LTS issued an URGENT: Medical Device Removal, Initial Notification to its consignees on 05/22/2025 via telephone and email. The notice explained the issue, the risk to health, and requested the following: Actions to be taken by the distributor: 1. Please stop all distribution of IontoPatch STAT Lot # s 4283-1, 4283-2, 4283-3, 4283-4 and IontoPatch 80 Lot # s 4303-1, 4303-2, 4303-3. 2. Contact your clients to which these product lot # s have been distributed and instruct them to cease all sales, distribution and/or usage. Further Actions: 1. This initial notification is to stop further di |
| Quantity | 63936 units |
| Distribution | US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992708 | IONTOPATCH Birch Point Medical, Inc., Feb 1, 2000 |