LTS Therapy Systems, LLC recalls IontoPatch STAT

The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.

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

• FDA enforcement recordOfficial FDA database entry for Z-2196-2025
• FDA 510(k) clearance · K992708The device's official FDA premarket clearance record
• FDA device classification · EGJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 890.5525The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find LTS Therapy Systems, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.