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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

SoClean, Inc: SoClean 2 and 3 Maintenance Systems Recalled Due to Ozone Gas Exposure Risk

Agency Publication Date: January 10, 2024
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Summary

SoClean, Inc. is recalling approximately 2,379,427 units of its SoClean 2 and SoClean 3 automated sleep equipment maintenance systems. The recall was initiated because using these devices can lead to potential health risks from exposure to ozone gas if not used with proper ventilation and specific equipment adapters. The company is providing a new user manual with updated instructions and a specialized hose and mask adapter to ensure safe operation. Consumers should contact SoClean to receive these updated materials and the necessary adapter kit.

Risk

The devices use ozone to maintain sleep equipment, but without the newly provided manufacturer adapters and updated instructions, users may be inadvertently exposed to ozone gas. Ozone exposure can cause respiratory issues and other health complications.

What You Should Do

  1. Identify if you have an affected device by checking the model name and reference number: SoClean 3 (REF SC1400) with UDI (01)00858242007147 or SoClean 2 (REF SC1200) with UPC 187293000860.
  2. Check the labeling on your device or the original packaging for the UPC code 187293000860 or the UDI (01)00858242007147.
  3. Contact SoClean, Inc. to obtain the new User Manual and the required hose and mask adapter provided by the manufacturer to reduce ozone exposure risks.
  4. Follow the additional instructions for use included in the new manual strictly to ensure the device is operated safely.
  5. Contact your healthcare provider if you have experienced any respiratory issues or health concerns related to the use of this device.
  6. For further questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

New User Manual and Adapter

How to: Contact your healthcare provider or the manufacturer for the updated user manual and a hose and mask adapter to reduce health risks.

Affected Products

Product: SoClean 3 Automated Supplemental Sleep Equipment Maintenance System
Model / REF:
SC1400
Product: SoClean 2 Supplemental Hose and Mask Maintenance System
Model / REF:
SC1200
UPC Codes:
187293000860

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93570
Status: Active
Manufacturer: SoClean, Inc
Sold By: authorized dealers; specialty retailers
Manufactured In: United States
Units Affected: 2 products (40,075; 2,339,352)
Distributed To: Nationwide

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.