RoyalVibe Health Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0082-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls

Product Classification:

Class II

Date Initiated: August 30, 2023

Date Posted: October 18, 2023

Recall Number: Z-0082-2024

Event ID: 92789

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 564

Code Information:

CellQuicken Analyzer (Smart-Watch and Software), Software Version: 1,39. All distributed products manufactured between January 2020 and June 2022.

Distribution Pattern:

US: MI, PA, TX, GA, OH, CA, FL, NY, NH, UT, AL, WA. WI, MN, MA, NM, IA, MD, IL, SC, NJ, NC, NV, TN, AZ, OR, OK, LA, OR, NE, ME, CO, MS, MT, CT, KY, HI, IN, DC

Voluntary or Mandated:

Voluntary: Firm initiated