FDA Device recall Z-1347-2022
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
- FDA Device
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000 by Zeltiq Aesthetics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1347-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-09 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Zeltiq Aesthetics |
| Distribution | 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, WY |
Product
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
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.
Identifiers
| code_info | CoolCore REF: BRZ-AP1-063-000 BRZ-AP1-063-000_F BRZ-AP1-063-000_K BRZ-AP1-063-000_R UDI-DI: 00816417020179 Serial Nu…CoolCore REF: BRZ-AP1-063-000 BRZ-AP1-063-000_F BRZ-AP1-063-000_K BRZ-AP1-063-000_R UDI-DI: 00816417020179 Serial Numbers: V0632018051020 V0632018051019 V0632018051018 V0632018051013 V0632018051009 V0632018051008 V0632018044020 V0632018024017 V0632018024002 V0632017292006 V0632017117013 V0632017108003 V0632017108001 V0632017100014 V0632016197018 V0632016140020 V0632016140019 V0632016140018 V0632016140017 V0632016140016 V0632016140015 V0632016140014 V0632016140012 V0632016140011 V0632016140008 V0632016140007 V0632016140006 V0632016140004 V0632016140003 V0632016140002 V0632016140001 V0632016139020 V0632016139019 V0632016139016 V0632016139015 V0632016139014 V0632016139013 V0632016139012 V0632016139011 V0632016139009 V0632016139008 V0632016139007 V0632016139006 V0632016139005 V0632016139004 V0632016139003 V0632016139001 V0632016133019 V0632016133018 V0632016133016 V0632016133015 V0632016133011 V0632016133009 V0632016133007 V0632016133004 V0632016133003 V0632016132017 V0632016132016 V063 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1347-2022%22
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