FDA Medical Device Recalls (openFDA)
LTS Therapy Systems, LLC: IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
- Recall number
- Z-2197-2025
- Recalling firm
- LTS Therapy Systems, LLC
- Product
- IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
- Status
- Open, Classified
- Initiated
- 2025-05-22
- Posted
- 2025-07-29
- Terminated
- not on file
- 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 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
- 63936 units
- Distribution
- US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.
- Lot, serial or model codes
- Lot Code: UDI-DI: (01) 10815611020012 UDI-PI: (10) 4303 Lot numbers: 4303-1, 4303-2, 4303-3
- 510(k) numbers
- ["K992708"]
- PMA numbers
- not on file
- Product code
- EGJ
- Firm FEI
- 2182681
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28