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U.S. Department of Health and Human Services

Class 2 Device Recall IontoPatch

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 Class 2 Device Recall IontoPatchsee related information
Date Initiated by FirmMay 22, 2025
Date PostedJuly 29, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2196-2025
Recall Event ID 97146
510(K)NumberK992708 
Product Classification Device, iontophoresis, other uses - Product Code EGJ
ProductIontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
Code Information Lot Code: UDI-DI: (01) 10815611020005 UDI-PI: (10) 4283 Lot numbers: 4283-1, 4283-2, 4283-3, 4283-4
FEI Number 2182681
Recalling Firm/
Manufacturer		 LTS Therapy Systems, LLC
1685 Marthaler Ln
Saint Paul MN 55118-3517
For Additional Information ContactSteve Leno
1-651-5525622
Manufacturer 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 2		Under Investigation by firm
ActionLTS 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
Quantity in Commerce80928 units
DistributionUS Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EGJ
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