SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt — Class II medical device recall Z-0444-2021
Terminated recall by Aesthetics Biomedical, Inc., reported 2020-11-18, distributed nationwide. A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
| Recall number | Z-0444-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesthetics Biomedical, Inc., Phoenix, AZ, United States |
| Recall initiated | 2020-03-13 |
| Classified | 2020-11-12 |
| Reported by FDA | 2020-11-18 |
| Terminated | 2021-09-01 |
| Distributed | Nationwide (US) |
| Quantity | 623 units |
| UPC / GTIN / UDI-DI | 08800017100326 |
Product
SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
Reason for recall
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
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-0444-2021. 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.