IontoPatch recallZ-2196-2025 · LTS Therapy Systems, LLC · initiated May 22, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from LTS Therapy Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
FDA root cause category: Under Investigation by firm
What the company is doing
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: [email protected]; Ph: 651-552-5622
Recall details
- Recall number
- Z-2196-2025
- Status
- Open, Classified
- Initiated by the company
- May 22, 2025
- Posted by the FDA
- Jul 29, 2025
- Recalling firm
- LTS Therapy Systems, LLC
- Quantity
- 80928 units
- Product code
- EGJ
- FDA submissions
- K992708
- Distribution
- US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.
Product description
IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
Code information (models, lots, serial numbers)
Lot Code: UDI-DI: (01) 10815611020005 UDI-PI: (10) 4283 Lot numbers: 4283-1, 4283-2, 4283-3, 4283-4
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IontoPatch STATLTS Therapy Systems, LLC · Device, Iontophoresis, Other Uses1 recall0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K992708 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- IontoPatch 80LTS Therapy Systems, LLC · Device, Iontophoresis, Other Uses1 recall0 reports
- Travanti STATLTS Therapy Systems, LLC1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 97146).
- Z-2197-2025 · Open, ClassifiedIontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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