Saint Paul, MN, United States
LTS Therapy Systems, LLC recalls
1 recall recorded since 2018, most recently on 22 May 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 22 May 2025
- Reason
- The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
- Distribution
- US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2197-2025, Z-2196-2025
- IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
- IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.