Z-2196-2025Class II

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

Name: Z-2196-2025 IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis...
Creator: LTS Therapy Systems, LLC
Published: 2025-05-22
License: https://open.fda.gov/license/

LTS Therapy Systems, LLC / initiated 2025-05-22 / Open, Classified

FDA source

LTS Therapy Systems, LLC began a recall of IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch on 2025-05-22. FDA classified it as Class II and gives the reason as "The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2196-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-22
Posted: 2025-07-29
Recalling firm: LTS Therapy Systems, LLC
Product: IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
Product code: EGJ Device, Iontophoresis, Other Uses
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 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: [email protected]; Ph: 651-552-5622
Quantity in commerce: 80928 units
Distribution: US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.
Product codes and lots: Lot Code: UDI-DI: (01) 10815611020005 UDI-PI: (10) 4283 Lot numbers: 4283-1, 4283-2, 4283-3, 4283-4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2196-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2196-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-29
Z-2197-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-29

Product code EGJ

K992708Class IIIontopatchBirch Point Medical, Inc. / cleared 2000-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)