Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Recalled by Aesthetics Biomedical, Inc. Due to A high frequency output (2 MHz) has not...

Date: March 13, 2020
Company: Aesthetics Biomedical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Aesthetics Biomedical, Inc. directly.

Affected Products

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.

Quantity: 623 units

Why Was This Recalled?

A high frequency output (2 MHz) has not been cleared for distribution in the U.S.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Aesthetics Biomedical, Inc.

Aesthetics Biomedical, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report