# FDA recall Z-2196-2025

> **LTS Therapy Systems, LLC** · Class II · device recall initiated 2025-05-22.

## Product

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

## 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.

## Distribution

US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.

## Key facts

- **Recall number:** Z-2196-2025
- **Recalling firm:** LTS Therapy Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-22
- **Report date:** 2025-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2196-2025

## Citation

> AI Analytics. FDA recall Z-2196-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2196-2025. Source: US FDA. Licensed CC0.

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