Recall Z-2197-2025
LTS Therapy Systems, LLC · initiated May 22, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
Codes / lots: Lot Code: UDI-DI: (01) 10815611020012 UDI-PI: (10) 4303 Lot numbers: 4303-1, 4303-2, 4303-3
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.
FDA-determined cause: Under Investigation by firm
Action taken
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 distribution of products only. In the coming days, LTS will request the following: a. The quantity of each product and lot # s listed above at your facility b. The quantity of each product and lot # s listed above that you have distributed c. The companies name and address where products have been sold, along with the quantities of each product and lot number sold d. The remaining quantity of each product and lot number at all company locations where product was sold 2. LTS will provide information for the return and reimbursement of products. Please contact Steve Leno for any questions or additional information: Email: steve.leno@ltslohmann.com; Ph: 651-552-5622
Details
- Recall number
- Z-2197-2025
- Initiated
- May 22, 2025
- Posted by FDA
- July 29, 2025
- Product code
- EGJ – Device, Iontophoresis, Other Uses
- Quantity
- 63936 units
- Distribution
- US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.
- Recalling firm
- LTS Therapy Systems, LLC, Saint Paul, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2196-2025 Class II | IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is…The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used… | 05/22/2025Open, Classified |