# FDA recall Z-0082-2024

> **RoyalVibe Health Ltd.** · Class II · device recall initiated 2023-08-30.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0082-2024
- **Recalling firm:** RoyalVibe Health Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-30
- **Report date:** 2023-10-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** The Woodlands, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0082-2024

## Citation

> AI Analytics. FDA recall Z-0082-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0082-2024. Source: US FDA. Licensed CC0.

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