IontoPatch STAT recall
IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
Why was IontoPatch STAT recalled?
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: UDI-DI: (01) 10815611020005 UDI-PI: (10) 4283 Lot numbers: 4283-1, 4283-2, 4283-3, 4283-4
- Product
- IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
- Recalling firm
- LTS Therapy Systems, LLC
- Quantity
- 80928 units
- Distribution
- US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.
- Recall date
- August 6, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)