Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000 Recalled by Zeltiq Aesthetics, Inc Due to Executing a voluntary discontinuation and removal of parallel...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zeltiq Aesthetics, Inc directly.
Affected Products
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
Quantity: 2,684 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zeltiq Aesthetics, Inc
Zeltiq Aesthetics, Inc has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report