FDA Device recall Z-1346-2022
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
- FDA Device
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 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-1346-2022 |
| 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
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
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 | CoolMax BRZ-AP1-080-000 BRZ-AP1-080-000-R UDI-DI: 00816417020230 Serial Numbers: V082010246001 V0802018039018 V080201…CoolMax BRZ-AP1-080-000 BRZ-AP1-080-000-R UDI-DI: 00816417020230 Serial Numbers: V082010246001 V0802018039018 V0802017153007 V0802017138015 V0802017138013 V0802016258020 V0802016258017 V0802016258014 V0802016258012 V0802016258008 V0802016258006 V0802016258003 V0802016235037 V0802016235032 V0802016235030 V0802016235024 V0802016235022 V0802016235017 V0802016235016 V0802016235010 V0802016235002 V0802016229019 V0802016229018 V0802016229012 V0802016229010 V0802016229009 V0802016229008 V0802016229003 V0802016218011 V0802016218009 V0802016217010 V0802016217008 V0802016217005 V0802016217004 V0802016217002 V0802016214036 V0802016214033 V0802016214031 V0802016214029 V0802016214022 V0802016214021 V0802016214013 V0802016214012 V0802016214010 V0802016214009 V0802016214008 V0802016214007 V0802016214006 V0802016214005 V0802016214004 V0802016214003 V0802016214001 V0802016208010 V0802016208009 V0802016208008 V0802016208003 V0802016208002 V0802016207040 V0802016207039 V0802016207038 V0802016207035 V08 |
|---|
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-1346-2022%22
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