Home / Brands / Zeltiq Aesthetics
Zeltiq Aesthetics Recalls
6 recalls on record · September 8, 2021 to July 20, 2022 · Medical Devices
Recalls by year
21
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 20, 2022Medical DevicesFDA
Zeltiq Aesthetics, Inc recalls CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
Hazard: 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.
July 20, 2022Medical DevicesFDA
Zeltiq Aesthetics, Inc recalls CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
Hazard: 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.
July 20, 2022Medical DevicesFDA
Zeltiq Aesthetics, Inc recalls CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
Hazard: 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.
July 20, 2022Medical DevicesFDA
Zeltiq Aesthetics, Inc recalls CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
Hazard: 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.
July 20, 2022Medical DevicesFDA
Zeltiq Aesthetics, Inc recalls CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
Hazard: 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.
September 8, 2021Medical DevicesFDA
Zeltiq Aesthetics, Inc recalls CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Hazard: An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to re-treating the affected anatomic area within 24 hours, 2) Not reporting a thermal event or any other error codes causing a user to continue treating without being aware that a thermal event has occurred.