CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000 — FDA record Z-1350-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 9, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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.
Classification
Class II
Recalling firm
Zeltiq Aesthetics, Inc
Quantity
2,684 units
Agency-reported status
Ongoing
Source record identifier
Z-1350-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityCoolCurve 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 V0662016137004 V0662016137001 V0662016123020 V0662016123017 V0662016123016 V0662016123009 V0662016123007 V0662016123006 V0662016123005 V0662016123003 V0662016123002 V0662016120020 V0662016120019 V0662016120018 V0662016120015 V0662016120011 V0662016120010 V0662016120009 V0662016120008 V0662016120007 V0662016120004 V0662016120003 V0662016113020 V0662016113019 V0662016113017 V0662016113015 V0662016113014 V0662016113013 V0662016113012 V0662016113010 V0662016113009 V0662016113008 V0662016113007 V0662016113006 V0662016113005 V0662016113004 V0662016113003 V0662016113002 V0662016113001 V0662016112020 V0662016112018 V0662016112017 V0662016112016 V0662016112014 V0662016112009 V0662016105014 V0662016105013 V0662016105010 V0662016105007 V0662016105006 V0662016105005 V0662016105004 V0662016105003 V0662016105001 V0662016104020 V0662016104019 V0662016104018 V0662016104016 V0662016104015 V0662016104014 V0662016104013 V0662016104012 V0662016104010 V0662016104009 V0662016104008 V0662016104007 V0662016104006 V0662016104004 V0662016104003 V0662016104002 V0662016104001 V0662016103020 V0662016103019 V0662016103016 V0662016103015 V0662016103014 V0662016103012 V0662016103010 V0662016103008 V0662016103006 V0662016103005 V0662016103004 V0662016103003 V0662016103001 V0662016099020 V0662016099019 V0662016099018 V0662016099016 V0662016099015 V0662016099014 V0662016099012 V0662016099011 V0662016099009 V0662016099008 V0662016099007 V0662016099001 V0662016097019 V0662016097018 V0662016097016 V0662016097009 V0662016097006 V0662016097005 V0662016097003 V0662016097001 V0662016095020 V0662016095019 V0662016095018 V0662016095017 V0662016095016 V0662016095015 V0662016095014 V0662016095013 V0662016095012 V0662016095010 V0662016095009 V0662016095008 V0662016095007 V0662016095006 V0662016095005 V0662016095004 V0662016095003 V0662016095002 V0662016095001 V0662016091018 V0662016091017 V0662016091011 V0662016091008 V0662016084003 V0662016084001 V0662016083008 V0662016083006 V0662016083004 V0662016083003 V0662016064012 V0662016064005 V0662016064003 V0662016064002 V0662016064001 V0662016063015 V0662016063014 V0662016063011 V0662016063008 V0662016063005 V0662016063001 V0662016062020 V0662016062019 V0662016062018 V0662016062016 V0662016062014 V0662016062012 V0662016062011 V0662016062010 V0662016062008 V0662016062007 V0662016062006 V0662016062005 V0662016062003 V0662016062001 V0662016055004 V0662016041020 V0662016041018 V0662016041014 V0662016041013 V0662016041012 V0662016041011 V0662016041008 V0662016041007 V0662016041004 V0662016041003 V0662016041001 V0662016040020 V0662016040017 V0662016040016 V0662016040014 V0662016040012 V0662016040011 V0662016040008 V0662016040006 V0662016040005 V0662016040004 V0662016040003 V0662016040002 V0662016036038 V0662016036033 V0662016036030 V0662016036027 V0662016036026 V0662016036022 V0662016036018 V0662016036015 V0662016036004 V0662016034019 V0662016034015 V0662016034010 V0662016034008 V0662016034006 V0662016034005 V0662016034004 V0662016034003 V0662016034002 V0662016032020 V0662016032016 V0662016032013 V0662016032012 V0662016032009 V0662016032007 V0662016032005 V0662016032004 V0662016032003 V0662016032002 V0662016022020 V0662016022017 V0662016022016 V0662016022015 V0662016022014 V0662016022013 V0662016022012 V0662016022011 V0662016022010 V0662016022008 V0662016022007 V0662016022006 V0662016022005 V0662016022002 V0662016019020 V0662016019017 V0662016019016 V0662016019013 V0662016019011 V0662016019010 V0662016019009 V0662016019006 V0662016019005 V0662016019004 V0662016019003 V0662016019001 V0662016014019 V0662016014016 V0662016014015 V0662016014014 V0662016014013 V0662016014012 V0662016014011 V0662016014010 V0662016014007 V0662016014006 V0662016014004 V0662016014003 V0662016007019 V0662016007018 V0662016007017 V0662016007016 V0662016007015 V0662016007011 V0662016007008 V0662016007007 V0662016007006 V0662016007005 V0662016007003 V0662016007002 V0662016007001 V0662016005020 V0662016005019 V0662016005018 V0662016005016 V0662016005015 V0662016005014 V0662016005013 V0662016005012 V0662016005010 V0662016005009 V0662016005007 V0662016005006 V0662016005005 V0662016005003 V0662016005002 V0662016005001 V0662016004020 V0662016004019 V0662016004018 V0662016004016 V0662016004015 V0662016004014 V0662016004013 V0662016004012 V0662016004011 V0662016004010 V0662016004009 V0662016004008 V0662016004007 V0662016004006 V0662016004003 V0662015293020 V0662015293018 V0662015293017 V0662015293016 V0662015293010 V0662015293008 V0662015293007 V0662015293006 V0662015293005 V0662015293004 V0662015293002 V0662015293001 V0662015280018 V0662015280016 V0662015280014 V0662015280013 V0662015280012 V0662015280011 V0662015280010 V0662015280007 V0662015280006 V0662015280005 V0662015280001 V0662015273016 V0662015273015 V0662015273014 V0662015273012 V0662015273011 V0662015273010 V0662015273009 V0662015273008 V0662015273007 V0662015273006 V0662015273002 V0662015267019 V0662015267018 V0662015267017 V0662015267016 V0662015267013 V0662015267012 V0662015267010 V0662015267008 V0662015267006 V0662015267005 V0662015260013 V0662015260011 V0662015260010 V0662015260009 V0662015260005 V0662015260004 V0662015260003 V0662015260002 V0662015260001 V0662015245018 V0662015243020 V0662015243018 V0662015243017 V0662015243016 V0662015243015 V0662015243014 V0662015243012 V0662015243011 V0662015243010 V0662015243009 V0662015243008 V0662015243007 V0662015243006 V0662015243005 V0662015243004 V0662015243003 V0662015243002 V0662015243001 V0662015239016 V0662015239014 V0662015239012 V0662015239011 V0662015239009 V0662015239006 V0662015239005 V0662015239002 V0662015239001 V0662015233040 V0662015233039 V0662015233038 V0662015233037 V0662015233036 V0662015233035 V0662015233034 V0662015233033 V0662015233031 V0662015233030 V0662015233028 V0662015233027 V0662015233026 V0662015233024 V0662015233022 V0662015233021 V0662015233020 V0662015233019 V0662015233018 V0662015233016 V0662015233014 V0662015233011 V0662015233010 V0662015233009 V0662015233008 V0662015233007 V0662015233006 V0662015233005 V0662015233004 V0662015233002 V0662015233001 V0662015230019 V0662015230018 V0662015230017 V0662015230016 V0662015230015 V0662015230014 V0662015230013 V0662015230011 V0662015230007 V0662015230006 V0662015230003 V0662015229020 V0662015229019 V0662015229018 V0662015229017 V0662015229016 V0662015229013 V0662015229010 V0662015229009 V0662015229008 V0662015229007 V0662015229006 V0662015229004 V0662015229003 V0662015229001 V0662015223020 V0662015223019 V0662015223017 V0662015223014 V0662015223012 V0662015223011 V0662015223007 V0662015223006 V0662015223005 V0662015223004 V0662015223002 V0662015222020 V0662015222019 V0662015222017 V0662015222015 V0662015222014 V0662015222013 V0662015222012 V0662015222011 V0662015222010 V0662015222009 V0662015222008 V0662015222007 V0662015222004 V0662015222003 V0662015222001 V0662015219019 V0662015219017 V0662015219016 V0662015219009 V0662015219008 V0662015219007 V0662015219006 V0662015219005 V0662015219004 V0662015219003 V0662015219001 V0662015218020 V0662015218019 V0662015218018 V0662015218016 V0662015218014 V0662015218013 V0662015218012 V0662015218011 V0662015218010 V0662015218007 V0662015218004 V0662015218003 V0662015218001 V0662015216020 V0662015216018 V0662015216017 V0662015216016 V0662015216015 V0662015216014 V0662015216013 V0662015216012 V0662015216009 V0662015216008 V0662015216003 V0662015216001 V0662015215020 V0662015215019 V0662015215018 V0662015215017 V0662015215016 V0662015215014 V0662015215012 V0662015215009 V0662015215006 V0662015215005 V0662015215003 V0662015215001 V0662015210040 V0662015210039 V0662015210038 V0662015210037 V0662015210036 V0662015210035 V0662015210032 V0662015210031 V0662015210030 V0662015210025 V0662015210024 V0662015210023 V0662015210021 V0662015210020 V0662015210019 V0662015210015 V0662015210012 V0662015210011 V0662015210010 V0662015210009 V0662015210008 V0662015210006 V0662015210002 V0662015210001 V0662015209020 V0662015209019 V0662015209018 V0662015209017 V0662015209016 V0662015209015 V0662015209014 V0662015209013 V0662015209012 V0662015209011 V0662015209010 V0662015209007 V0662015209006 V0662015209005 V0662015209004 V0662015209003 V0662015209002 V0662015209001 V0662015208019 V0662015208016 V0662015208014 V0662015208012 V0662015208011 V0662015208010 V0662015208009 V0662015208008 V0662015208007 V0662015208006 V0662015208005 V0662015208004 V0662015208002 V0662015208001 V0662015204019 V0662015204018 V0662015204017 V0662015204016 V0662015204015 V0662015204012 V0662015204010 V0662015204007 V0662015204006 V0662015204003 V0662015204001 V0662015202019 V0662015202014 V0662015202012 V0662015202011 V0662015202010 V0662015202009 V0662015202006 V0662015202003 V0662015202002 V0662015202001 V0662015194058 V0662015194055 V0662015194054 V0662015194053 V0662015194051 V0662015194050 V0662015194046 V0662015194045 V0662015194044 V0662015194043 V0662015194042 V0662015194041 V0662015194040 V0662015194039 V0662015194038 V0662015194037 V0662015194034 V0662015194032 V0662015194031 V0662015194030 V0662015194028 V0662015194026 V0662015194024 V0662015194023 V0662015194022 V0662015194021 V0662015194020 V0662015194017 V0662015194016 V0662015194015 V0662015194012 V0662015194008 V0662015194006 V0662015194005 V0662015194004 V0662015194003 V0662015194002 V0662015194001 V0662015190020 V0662015190019 V0662015190013 V0662015190012 V0662015190011 V0662015190010 V0662015190009 V0662015190007 V0662015190006 V0662015190004 V0662015190003 V0662015190001 V0662015187020 V0662015187018 V0662015187017 V0662015187016 V0662015187014 V0662015187013 V0662015187011 V0662015187008 V0662015187007 V0662015187005 V0662015187003 V0662015187002 V0662015187001 V0662015181019 V0662015181018 V0662015181017 V0662015181012 V0662015181011 V0662015181010 V0662015181009 V0662015181008 V0662015181006 V0662015181001 V0662015177020 V0662015177017 V0662015177016 V0662015177014 V0662015177013 V0662015177012 V0662015177009 V0662015177008 V0662015177005 V0662015177004 V0662015177002 V0662015174020 V0662015174011 V0662015174010 V0662015174008 V0662015174005 V0662015174004 V0662015174002 V0662015174001 V0662015170020 V0662015170019 V0662015170018 V0662015170017 V0662015170016 V0662015170015 V0662015170014 V0662015170012 V0662015170011 V0662015170010 V0662015170006 V0662015170005 V0662015170003 V0662015170002 V0662015155017 V0662015155014 V0662015155013 V0662015155010 V0662015155008 V0662015155005 V0662015154019 V0662015154017 V0662015154015 V0662015154009 V0662015154007 V0662015154005 V0662015154003 V0662015154002 V0662015152020 V0662015152018 V0662015152017 V0662015152013 V0662015152012 V0662015152011 V0662015152010 V0662015152008 V0662015152007 V0662015152006 V0662015152005 V0662015152002 V0662015152001 V0662015147020 V0662015147019 V0662015147017 V0662015147015 V0662015147014 V0662015147013 V0662015147009 V0662015147001 V0662015146013 V0662015146011 V0662015146008 V0662015146004 V0662015146003 V0662015146002 V0662015141015 V0662015141013 V0662015141012 V0662015141010 V0662015141008 V0662015141007 V0662015141006...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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, Bolivia, Canada, Switzerland, China, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, The Republic of Korea, Kuwait, Lebanon, Luxembourg, Latvia, Mexico, The Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Sweden, Singapore, Thailand, Turkey, Taiwan, Uruguay, Venezuela, and South Africa.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Jul 20, 2022
Recall initiation date
Jun 9, 2022
Center classification date
Jul 11, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

Related records