RoyalVibe Health recalls unapproved ultrasound devices that could lead users to skip medical treatment. Products sold between Jan 2020 and June 2022 may pose health risks if relied on for medical purposes.
Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. There is a possibility of customers' reliance on marketing claims which could cause the user to forgo medical treatment resulting in health consequences.
RoyalVibe is recalling several ultrasound devices that haven't been approved by the FDA. These products might cause users to skip necessary medical treatment if they rely on the device's claims for health care.
These ultrasound devices were not approved by the FDA, so their safety and effectiveness for medical use aren't established. If users rely on the device's marketing claims to avoid medical care, they could face health consequences.
Users of the CellQuicken Analyzer smartwatch and software, RoyalVibe Ultrasound Generator, Brainvibe, and Envirovibe Water Restructuring Pad who bought them between January 2020 and June 2022 are affected. People who use these devices for medical purposes are at higher risk.
Check for the CellQuicken Analyzer smartwatch and software, RoyalVibe Ultrasound Generator, Brainvibe, or Envirovibe Water Restructuring Pad. Products were sold between January 2020 and June 2022.
Review the product name and software version to confirm if it matches the recalled items.
The FDA did not approve these devices, so their safety and effectiveness for medical use are not established.
The recall record does not specify a remedy, so no action is required beyond checking if your product matches the description.
Products were distributed between January 2020 and June 2022.
We’ve drafted a message you can send RoyalVibe to request your refund or repair — edit it as you like.
Subject: Recall Z-0082-2024 — RoyalVibe RoyalVibe Hello, I own a RoyalVibe that is covered by recall Z-0082-2024 from RoyalVibe. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
