RoyalVibe Unapproved Medical Devices Recalled Due to Lack of FDA Authorization
RoyalVibe Health recalled multiple unapproved medical devices including ultrasound generators and therapy devices never FDA-authorized or cleared. Users could forgo legitimate medical treatment based on unproven marketing claims.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II devices with no reported illnesses or injuries. The hazard is theoretical—possibility that users forego medical treatment—making this a risk-of-harm product without injury, which scores High per rubric.
Plain-English summary
RoyalVibe Health Ltd. has recalled multiple medical devices and wellness products: CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, and RoyalVibe Therapy Balls. Approximately 564 units were distributed across the United States between January 2020 and June 2022.
These devices were never authorized, cleared, or approved by the FDA. As a result, their performance characteristics and safety have not been adequately established through any regulatory review.
The FDA is concerned that customers may rely on marketing claims about these products as substitutes for legitimate medical treatment. If users forgo proper medical care in favor of these unproven devices, they could experience health consequences. No illnesses or injuries have been reported to date.
Consumers with these products should discontinue use and consult their healthcare provider with any questions about treatment alternatives.
The recalled product
- Product
- CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
- Manufacturer
- RoyalVibe Health Ltd.
- Hazard
- unauthorized-device
- unproven-performance
- treatment-avoidance-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- CellQuicken Analyzer (Smart-Watch and Software)
- Software Version: 1
- 39. All distributed products manufactured between January 2020 and June 2022.
Distribution
Distributed in 38 states:
- AL
- AZ
- CA
- CO
- CT
- DC
- FL
- GA
- HI
- IA
- IL
- IN
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MS
- MT
- NC
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- SC
- TN
- TX
- UT
- WA
- WI
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