CLASS II Device recall · Reported 18 Nov 2020 · FDA Enforcement Report
Sung Hwan E&b Vivace Shenb Innovation of Beauty Technologyt recalled
Aesthetics Biomedical is recalling Sung Hwan E&b Vivace Shenb Innovation of Beauty Technologyt, distributed nationwide in the US. The recall was initiated on 13 Mar 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0444-2021
- FDA event ID
- 85891
- Recalling firm
- Aesthetics Biomedical, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Mar 2020
- FDA classified
- 12 Nov 2020
- Reported
- 18 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 13 Mar 2020 | Recall initiated by company | |
| 12 Nov 2020 | Classified by FDA | +244 days |
| 18 Nov 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Is Sung Hwan E&b Vivace Shenb Innovation of Beauty Technologyt recalled?
Yes. Aesthetics Biomedical recalled Sung Hwan E&b Vivace Shenb Innovation of Beauty Technologyt on 13 Mar 2020. The recall is Class II and its status is Terminated. Recall number Z-0444-2021.
Why was it recalled?
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
Which lots are affected?
UDI Code: 08800017100326 All Lots/Serial Numbers: Serial Number range from 16019 to 20121. The Vivace Electrosurgical System is controlled by software system: VIVA-MA-01, V 1.0, Class B
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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