FDAJune 9, 2022device
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
zeltiq aestheticszeltiq
UPCs
00816417020193
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-0002022-06-09
- FDACoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-0002022-06-09
- FDACoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-0002022-06-09
- FDACoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-0002022-06-09
- FDAAction De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.2021-08-23
- FDACoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.22021-07-05
- FDASUNG 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.2020-03-13
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