FDA Device recall Z-1350-2022
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
- FDA Device
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000 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-1350-2022 |
| 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
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
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 | CoolCurve REF: BRZ-AP1-066-000 BRZ-AP1-064-000_R UDI-DI: 00816417020216 Serial Numbers: V0662016146015 V066201614601…CoolCurve REF: BRZ-AP1-066-000 BRZ-AP1-064-000_R UDI-DI: 00816417020216 Serial Numbers: V0662016146015 V0662016146014 V0662016146010 V0662016146007 V0662016146002 V0662016145016 V0662016145015 V0662016145010 V0662016145009 V0662016145008 V0662016145005 V0662016145004 V0662016145002 V0662016144019 V0662016144017 V0662016144016 V0662016144015 V0662016144014 V0662016144012 V0662016144009 V0662016144007 V0662016144003 V0662016140038 V0662016140037 V0662016140036 V0662016140035 V0662016140033 V0662016140032 V0662016140031 V0662016140030 V0662016140029 V0662016140028 V0662016140027 V0662016140024 V0662016140023 V0662016140021 V0662016140020 V0662016140018 V0662016140017 V0662016140014 V0662016140013 V0662016140011 V0662016140009 V0662016140007 V0662016140004 V0662016140003 V0662016140002 V0662016140001 V0662016137020 V0662016137019 V0662016137018 V0662016137016 V0662016137015 V0662016137014 V0662016137013 V0662016137012 V0662016137011 V0662016137010 V0662016137008 V0662016137006 V06620161 |
|---|
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-1350-2022%22
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