# FDA recall Z-0444-2021

> **Aesthetics Biomedical, Inc.** · Class II · device recall initiated 2020-03-13.

## 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.

## Distribution

U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.

## Key facts

- **Recall number:** Z-0444-2021
- **Recalling firm:** Aesthetics Biomedical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-13
- **Report date:** 2020-11-18
- **Termination date:** 2021-09-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Phoenix, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0444-2021

## Citation

> AI Analytics. FDA recall Z-0444-2021. Retrieved 2026-08-24 from https://api.ai-analytics.org/recall/Z-0444-2021. Source: US FDA. Licensed CC0.

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