Zeltiq Aesthetics, Inc recalls CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000

Recall date

June 9, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1347-2022

FDA classification

Class II

Brand / firm

Zeltiq Aesthetics, Inc

Sold / distributed

U.S. AK, AL, AR, 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, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: United Arab Emirates, Argentina, Austria, Australia, Belgium, Bahrain, Bol…

Why it was recalled

Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000