CellQuicken Analyzer — Class II medical device recall Z-0082-2024
Ongoing recall by RoyalVibe Health Ltd., reported 2023-10-18, distributed in AL, AZ, CA, CO, CT, DC, FL, GA…. Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristic
| Recall number | Z-0082-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RoyalVibe Health Ltd., The Woodlands, TX, United States |
| Recall initiated | 2023-08-30 |
| Classified | 2023-10-06 |
| Reported by FDA | 2023-10-18 |
| Distributed | 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 |
| Quantity | 564 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0082-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.