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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

RoyalVibe Health Ltd.: Unauthorized Ultrasound Devices and Health Analyzers Recalled

Agency Publication Date: October 6, 2023
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Summary

RoyalVibe Health Ltd. is recalling approximately 564 units of various health devices, including the CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, and RoyalVibe Therapy Balls. These products, manufactured between January 2020 and June 2022, were distributed without required FDA authorization or approval, meaning their safety and effectiveness have not been established. Because the manufacturer’s marketing claims have not been verified, there is a serious risk that consumers may rely on these devices instead of seeking professional medical treatment, which could lead to severe health consequences. Consumers are advised to stop using these products and contact their healthcare provider or the manufacturer.

Risk

The performance and safety of these devices have not been validated by the FDA. Users who rely on the unproven medical claims of these products may forgo or delay necessary medical care, allowing serious underlying health conditions to worsen without proper treatment.

What You Should Do

  1. Identify if you have any of the following affected products: CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, or RoyalVibe Therapy Balls.
  2. Check the software version if you own a CellQuicken Analyzer; Software Version 1.39 is specifically included in this recall.
  3. Verify if your device was manufactured between January 2020 and June 2022, as all products from this period are affected.
  4. If you have been using these devices to treat a medical condition, contact your healthcare provider immediately to discuss alternative, FDA-approved treatment options.
  5. Contact RoyalVibe Health Ltd. at their distributor location (1095 Evergreen Cir Ste 200, The Woodlands, Texas, 77380-3646) for further instructions regarding the return or disposal of these devices.
  6. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: CellQuicken Analyzer (Smart-Watch and Software)
Model / REF:
Software Version: 1.39
Lot Numbers:
Manufactured between January 2020 and June 2022
Product: RoyalVibe Ultrasound Generator
Lot Numbers:
Manufactured between January 2020 and June 2022
Product: Brainvibe
Lot Numbers:
Manufactured between January 2020 and June 2022
Product: Envirovibe Water Restructuring Pad
Lot Numbers:
Manufactured between January 2020 and June 2022
Product: RoyalVibe Therapy Balls
Lot Numbers:
Manufactured between January 2020 and June 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92789
Status: Active
Manufacturer: RoyalVibe Health Ltd.
Sold By: RoyalVibe Health Ltd.
Manufactured In: United States
Units Affected: 564
Distributed To: Michigan, Pennsylvania, Texas, Georgia, Ohio, California, Florida, New York, New Hampshire, Utah, Alabama, Washington, Wisconsin, Minnesota, Massachusetts, New Mexico, Iowa, Maryland, Illinois, South Carolina, New Jersey, North Carolina, Nevada, Tennessee, Arizona, Oregon, Oklahoma, Louisiana, Nebraska, Maine, Colorado, Mississippi, Montana, Connecticut, Kentucky, Hawaii, Indiana, District of Columbia

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 · FDA Press Release · 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.