Pleasanton, CA, United States
Zeltiq Aesthetics, Inc recalls
2 recalls recorded since 2018, most recently on 9 June 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 June 2022
- Reason
- 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.
- Distribution
- 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, Bo
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1346-2022, Z-1350-2022, Z-1348-2022, Z-1349-2022, Z-1347-2022
- CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
- CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
- CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
- CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
- CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
Terminated Class II Medical devices
- Recall started
- 5 July 2021
- Terminated
- 9 November 2023
- Reason
- 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.
- Distribution
- U.S.: AL, AR, AZ, CA, CO, CT, FL, GA,HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Italy, Norway, Sweden, France, Netherlands, Germany, Spain, United Kingdom, Portugal, South Korea
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2383-2021
- CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.