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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

IontoPatch Transdermal Patches Recalled Due to Absorption Failure

Agency Publication Date: July 29, 2025
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Summary

LTS Therapy Systems, LLC is recalling approximately 144,864 units of IontoPatch STAT and IontoPatch 80 "On-the-Go" transdermal patches. The nonwoven pads inside these devices fail to absorb saline solution or other liquids required for the iontophoresis treatment to work correctly. Without proper absorption, the patch cannot deliver the intended medication through the skin. No incidents or injuries have been reported to date.

Risk

The failure of the device to absorb liquids means patients will not receive the prescribed medical treatment, which can lead to ineffective therapy or delays in medical care.

What You Should Do

  1. This recall affects IontoPatch STAT (model D-0062-080) and IontoPatch 80 (model D-0077-080) transdermal patches.
  2. Check your device packaging for lot numbers 4283-1, 4283-2, 4283-3, 4283-4 (for STAT models) or 4303-1, 4303-2, 4303-3 (for IontoPatch 80 models).
  3. Stop using any patches that match the affected model and lot numbers immediately.
  4. Contact the manufacturer, LTS Therapy Systems, LLC, or your medical distributor to arrange for a return, replacement, or correction of the affected devices.
  5. If you have health concerns regarding a treatment you received using these patches, contact your healthcare provider.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: IontoPatch STAT, On-the-Go Patch Therapy
Model / REF:
D-0062-080
Lot Numbers:
4283-1
4283-2
4283-3
4283-4
UDI:
10815611020005

IontoPatch is an Iontophoresis transdermal patch.

Product: IontoPatch 80, On-the-Go Patch Therapy
Model / REF:
D-0077-080
Lot Numbers:
4303-1
4303-2
4303-3
UDI:
10815611020012

IontoPatch is an Iontophoresis transdermal patch.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97146
Status: Active
Manufacturer: LTS Therapy Systems, LLC
Sold By: medical distributors; healthcare providers
Manufactured In: United States
Units Affected: 2 products (80928 units; 63936 units)
Distributed To: Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, South Dakota

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.