Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CoolSculpting Elite System The CoolSculpting System SW release 2.0 Recalled by Zeltiq Aesthetics, Inc Due to An incorrect error messaging system that could potentially...
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
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Quantity: 911 systems (update 08/23/2021 = 1105 systems)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 43 states: AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY
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