Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall The CoolSculpting System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall The CoolSculpting Systemsee related information
Date Initiated by FirmJune 09, 2022
Create DateJuly 11, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1350-2022
Recall Event ID 90331
510(K)NumberK181740 
Product Classification Dermal cooling pack/vacuum/massager - Product Code OOK
ProductCoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
Code Information 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 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 V0662015141003 V0662015140018 V0662015140017 V0662015140016 V0662015140014 V0662015140011 V0662015140010 V0662015140009 V0662015140008 V0662015140006 V0662015140005 V0662015140001 V0662015138018 V0662015138016 V0662015138014 V0662015138011 V0662015138009 V0662015138008 V0662015138007 V0662015138006 V0662015138005 V0662015138004 V0662015138003 V0662015138001 V0662015133020 V0662015133019 V0662015133018 V0662015133016 V0662015133013 V0662015133010 V0662015133003 V0662015133002 V0662015131020 V0662015131018 V0662015131017 V0662015131016 V0662015131015 V0662015131014 V0662015131011 V0662015131007 V0662015131005 V0662015131004 V0662015127018 V0662015127017 V0662015127016 V0662015127015 V0662015127012 V0662015127010 V0662015127008 V0662015127006 V0662015127005 V0662015127002 V0662015127001 V0662015121010 V0662015121006 V0662015097020 V0662015097019 V0662015097018 V0662015097017 V0662015097015 V0662015097014 V0662015097013 V0662015097012 V0662015097011 V0662015097010 V0662015097009 V0662015097008 V0662015097007 V0662015097006 V0662015097005 V0662015097003 V0662015097002 V0662015097001 V0662015092020 V0662015092018 V0662015092017 V0662015092016 V0662015092014 V0662015092012 V0662015092011 V0662015092010 V0662015092009 V0662015092008 V0662015092006 V0662015092005 V0662015092004 V0662015092003 V0662015092002 V0662015092001 V0662015090010 V0662015090008 V0662015090006 V0662015090005 V0662015090004 V0662015090003 V0662015085009 V0662015085008 V0662015085007 V0662015085006 V0662015085005 V0662015085004 V0662015085002 V0662015085001 V0662015082019 V0662015082015 V0662015082014 V0662015082011 V0662015082010 V0662015082009 V0662015082008 V0662015082007 V0662015082006 V0662015082005 V0662015082004 V0662015082003 V0662015082002 V0662015082001 V0662015077020 V0662015077019 V0662015077017 V0662015077016 V0662015077015 V0662015077014 V0662015077013 V0662015077011 V0662015077010 V0662015077008 V0662015077007 V0662015077006 V0662015077004 V0662015077003 V0662015077002 V0662015077001 V0662015075020 V0662015075019 V0662015075018 V0662015075017 V0662015075016 V0662015075015 V0662015075014 V0662015075013 V0662015075011 V0662015075010 V0662015075009 V0662015075006 V0662015071009 V0662015069020 V0662015069016 V0662015069015 V0662015069014 V0662015069009 V0662015069006 V0662015069005 V0662015066019 V0662015066014 V0662015066012 V0662015066010 V0662015066008 V0662015066004 V0662015066003 V0662015066002 V0662015064019 V0662015064017 V0662015064013 V0662015064011 V0662015064010 V0662015064005 V0662015051020 V0662015051018 V0662015051013 V0662015051010 V0662015051007 V0662015051006 V0662015051002 V0662015050020 V0662015050019 V0662015050018 V0662015050017 V0662015050016 V0662015050014 V0662015050013 V0662015050011 V0662015050010 V0662015050009 V0662015050007 V0662015050006 V0662015050005 V0662015050004 V0662015050003 V0662015050001 V0662015048020 V0662015048018 V0662015048017 V0662015048015 V0662015048014 V0662015048013 V0662015048012 V0662015048011 V0662015048010 V0662015048009 V0662015048007 V0662015048005 V0662015048004 V0662015048003 V0662015043020 V0662015043019 V0662015043017 V0662015043015 V0662015043014 V0662015043013 V0662015043011 V0662015043010 V0662015043009 V0662015043008 V0662015043005 V0662015043003 V0662015043002 V0662015043001 V0662015040020 V0662015040019 V0662015040018 V0662015040013 V0662015040012 V0662015040011 V0662015040009 V0662015040007 V0662015040006 V0662015040005 V0662015040004 V0662015040002 V0662015040001 V0662015030020 V0662015030019 V0662015030018 V0662015030017 V0662015030016 V0662015030015 V0662015030014 V0662015030013 V0662015030012 V0662015030010 V0662015030009 V0662015030008 V0662015030007 V0662015030005 V0662015030004 V0662015030003 V0662015030002 V0662015030001 V0662015028019 V0662015028018 V0662015028017 V0662015028016 V0662015028015 V0662015028014 V0662015028013 V0662015028011 V0662015028010 V0662015028009 V0662015028008 V0662015028007 V0662015028006 V0662015028005 V0662015028004 V0662015027019 V0662015027018 V0662015027016 V0662015027015 V0662015027014 V0662015027013 V0662015027012 V0662015027011 V0662015027010 V0662015027009 V0662015027008 V0662015027007 V0662015027006 V0662015027005 V0662015027002 V0662015027001 V0662015022019 V0662015022018 V0662015022016 V0662015022015 V0662015022014 V0662015022010 V0662015022009 V0662015022007 V0662015016020 V0662015016019 V0662015016018 V0662015016017 V0662015016016 V0662015016015 V0662015016013 V0662015016011 V0662015016010 V0662015016009 V0662015016008 V0662015016007 V0662015016005 V0662015016004 V0662015016003 V0662015016001 V0662015013020 V0662015013019 V0662015013018 V0662015013017 V0662015013016 V0662015013015 V0662015013012 V0662015013010 V0662015013008 V0662015013007 V0662015013006 V0662015013005 V0662015013004 V0662015013003 V0662015012020 V0662015012019 V0662015012017 V0662015012015 V0662015008015 V0662015008012 V0662015008010 V0662015008004 V0662015008002 V0662015008001 V0662015005020 V0662015005018 V0662015005015 V0662015005012 V0662015005011 V0662014353019 V0662014353016 V0662014353013 V0662014353010 V0662014353008 V0662014353004 V0662014353002 V0662014351010 V0662014350011 V0662014350006 V0662014350001 V0662014349008 V0662014349002 V0662014343020 V0662014343016 V0662014343010 V0662014343006 V0662014337019 V0662014337018 V0662014337016 V0662014337015 V0662014337014 V0662014337013 V0662014337012 V0662014337011 V0662014337008 V0662014337006 V0662014337001 V0662014335017 V0662014335016 V0662014335015 V0662014335014 V0662014335009 V0662014335008 V0662014335007 V0662014335004 V0662014335003 V0662014335002 V0662014335001 V0662014328017 V0662014328015 V0662014328011 V0662014328009 V0662014328008 V0662014328006 V0662014328004 V0662014328003 V0662014328001 V0662014325020 V0662014325018 V0662014325017 V0662014325016 V0662014325015 V0662014325014 V0662014325013 V0662014325012 V0662014325011 V0662014325010 V0662014325009 V0662014325008 V0662014325006 V0662014325004 V0662014325002 V0662014324020 V0662014324019 V0662014324018 V0662014324017 V0662014324015 V0662014324013 V0662014324012 V0662014324011 V0662014324010 V0662014324009 V0662014324008 V0662014324007 V0662014324006 V0662014324005 V0662014324004 V0662014324003 V0662014324001 V0662014322020 V0662014322019 V0662014322017 V0662014322015 V0662014322014 V0662014322013 V0662014322012 V0662014322009 V0662014322006 V0662014322005 V0662014322004 V0662014322002 V0662014322001 V0662014318020 V0662014318019 V0662014318018 V0662014318017 V0662014318016 V0662014318015 V0662014318014 V0662014318013 V0662014318012 V0662014318011 V0662014318008 V0662014318006 V0662014318005 V0662014318004 V0662014318003 V0662014318002 V0662014318001 V0662014316019 V0662014316018 V0662014316017 V0662014316016 V0662014316015 V0662014316014 V0662014316011 V0662014316009 V0662014316007 V0662014316006 V0662014316003 V0662014316002 V0662014316001 V0662014314020 V0662014314017 V0662014314016 V0662014314014 V0662014314013 V0662014314012 V0662014314011 V0662014314010 V0662014314009 V0662014314008 V0662014314007 V0662014314006 V0662014314004 V0662014314003 V0662014314002 V0662014314001 V0662014308019 V0662014308018 V0662014308016 V0662014308014 V0662014308013 V0662014308010 V0662014308007 V0662014308005 V0662014308004 V0662014308003 V0662014308001 V0662014302020 V0662014302019 V0662014302018 V0662014290017 V0662014290016 V0662014290015 V0662014290014 V0662014290011 V0662014290009 V0662014290008 V0662014290007 V0662014290006 V0662014290004 V0662014290002 V0662014290001 V0662014280020 V0662014280018 V0662014280017 V0662014280016 V0662014280015 V0662014280014 V0662014280013 V0662014280011 V0662014280010 V0662014280009 V0662014280008 V0662014280007 V0662014280006 V0662014280005 V0662014280003 V0662014280002 V0662014266019 V0662014266014 V0662014266012 V0662014266008 V0662014266007 V0662014266005 V0662014266004 V0662014266001 V0662014265018 V0662014265017 V0662014265016 V0662014265013 V0662014265012 V0662014265011 V0662014265008 V0662014265007 V0662014265006 V0662014265005 V0662014265004 V0662014265001 V0662014259019 V0662014259018 V0662014259015 V0662014259011 V0662014259010 V0662014259008 V0662014259006 V0662014259005 V0662014259004 V0662014259003 V0662014259002 V0662014259001 V0662014254017 V0662014254016 V0662014254015 V0662014254009 V0662014254007 V0662014254006 V0662014254005 V0662014254004 V0662014254003 V0662014254002 V0662014254001 V0662014252019 V0662014252017 V0662014252016 V0662014252013 V0662014252011 V0662014252010 V0662014252009 V0662014252008 V0662014252005 V0662014252003 V0662014252002 V0662014252001 V0662014245018 V0662014245016 V0662014245010 V0662014245009 V0662014245008 V0662014245007 V0662014245004 V0662014245003 V0662014245002 V0662014245001 V0662014240017 V0662014240016 V0662014240015 V0662014240014 V0662014240012 V0662014240011 V0662014240008 V0662014240004 V0662014240002 V0662014237020 V0662014237016 V0662014237015 V0662014237013 V0662014237012 V0662014237009 V0662014237008 V0662014237007 V0662014237005 V0662014237003 V0662014237002 V0662014237001 V0662014230020 V0662014230019 V0662014230015 V0662014230014 V0662014230012 V0662014230009 V0662014230008 V0662014230006 V0662014230004 V0662014230003 V0662014230002 V0662014224012 V0662014224011 V0662014224010 V0662014224007 V0662014224006 V0662014224005 V0662014224004 V0662014224003 V0662014224002 V0662014217018 V0662014217017 V0662014217016 V0662014217015 V0662014217013 V0662014217012 V0662014217009 V0662014217008 V0662014217007 V0662014217006 V0662014217004 V0662014217003 V0662014217001 V0662014212020 V0662014212019 V0662014212018 V0662014212017 V0662014212016 V0662014212015 V0662014212014 V0662014212013 V0662014212010 V0662014212009 V0662014212008 V0662014212006 V0662014212005 V0662014212004 V0662014212003 V0662014212002 V0662014212001 V0662014209014 V0662014209013 V0662014209012 V0662014209009 V0662014209007 V0662014209006 V0662014209005 V0662014209003 V0662014209001 V0662014204020 V0662014204012 V0662014204011 V0662014204009 V0662014204007 V0662014204005 V0662014204003 V0662014204002 V0662014204001 V0662014202020 V0662014202019 V0662014202017 V0662014202016 V0662014202015 V0662014202014 V0662014202012 V0662014202011 V0662014202009 V0662014202008 V0662014202001 V0662014191020 V0662014191018 V0662014191017 V0662014191016 V0662014191014 V0662014191013 V0662014191012 V0662014191011 V0662014191010 V0662014191008 V0662014191007 V0662014191004 V0662014191003 V0662014191001 V0662014178019 V0662014178017 V0662014178016 V0662014178014 V0662014178013 V0662014178011 V0662014178010 V0662014178009 V0662014178007 V0662014178006 V0662014178005 V0662014178002 V0662014178001 V0662014177020 V0662014177019 V0662014177016 V0662014177014 V0662014177011 V0662014177010 V0662014177009 V0662014177006 V0662014177005 V0662014177004 V0662014177002 V0662014177001 V0662014176019 V0662014176018 V0662014176017 V0662014176016 V0662014176015 V0662014176014 V0662014176013 V0662014176012 V0662014176011 V0662014176007 V0662014176006 V0662014176004 V0662014176003 V0662014176002 V0662014175020 V0662014175019 V0662014175018 V0662014175017 V0662014175015 V0662014175013 V0662014175012 V0662014175011 V0662014175009 V0662014175007 V0662014175006 V0662014175005 V0662014175004 V0662014175003 V0662014175002 V0662014175001 V0662014174019 V0662014174017 V0662014174016 V0662014174015 V0662014174013 V0662014174012 V0662014174008 V0662014174007 V0662014174006 V0662014174005 V0662014174004 V0662014174003 V0662014169020 V0662014169018 V0662014169017 V0662014169016 V0662014169014 V0662014169013 V0662014169011 V0662014169010 V0662014169009 V0662014169007 V0662014169006 V0662014169005 V0662014169004 V0662014169003 V0662014169001 V0662014155003 V0662014155002 V0662014155001 V0662014134015 V0662014134014 V0662014134013 V0662014134011 V0662014134008 V0662014134007 V0662014134006 V0662014134003 V0662014134002 V0662014120020 V0662014120019 V0662014120017 V0662014120016 V0662014120015 V0662014120014 V0662014120010 V0662014115019 V0662014115018 V0662014115017 V0662014115016 V0662014115015 V0662014115014 V0662014115010 V0662014115002 V0662014097020 V0662014097018 V0662014097017 V0662014097016 V0662014097015 V0662014097013 V0662014097011 V0662014097010 V0662014097009 V0662014097008 V0662014097007 V0662014097006 V0662014097005 V0662014097003 V0662014097002 V0662014092015 V0662014092014 V0662014092012 V0662014092011 V0662014092010 V0662014092007 V0662014092005 V0662014092004 V0662014092003 V0662014092002 V0662014092001 V0662014090016 V0662014090012 V0662014090011 V0662014090008 V0662014090006 V0662014090002 V0662014090001 V0662014083015 V0662014083013 V0662014083012 V0662014083010 V0662014083009 V0662014083007 V0662014083004 V0662014083003 V0662014083002 V0662014077015 V0662014077014 V0662014077013 V0662014077012 V0662014077010 V0662014077007 V0662014077006 V0662014077005 V0662014077004 V0662014077002 V0662014077001 V0662014072016 V0662014072015 V0662014072014 V0662014072013 V0662014072012 V0662014072011 V0662014072009 V0662014072008 V0662014072006 V0662014072003 V0662014072002 V0662014072001 V0662014070015 V0662014070013 V0662014070011 V0662014070009 V0662014070008 V0662014070006 V0662014070005 V0662014070004 V0662014070002 V0662014070001 V0662014066016 V0662014066015 V0662014066014 V0662014066013 V0662014066011 V0662014066010 V0662014066009 V0662014066008 V0662014066007 V0662014066002 V0662014066001 V0662014064016 V0662014064010 V0662014064009 V0662014064006 V0662014064005 V0662014064004 V0662014064003 V0662014064002 V0662014064001 V0662014057016 V0662014057014 V0662014057013 V0662014057011 V0662014057010 V0662014057009 V0662014057001 V0662014051016 V0662014051015 V0662014051010 V0662014051009 V0662014051007 V0662014051004 V0662014049016 V0662014049010 V0662014049006 V0662014049004 V0662014049003 V0662014044012 V0662014044007 V0662014042014 V0662014042013 V0662014042010 V0662014042009 V0662014042008 V0662014042003 V0662014039016 V0662014039010 V0662014039009 V0662014039008 V0662014039006 V0662014039005 V0662014039004 V0662014039003 V0662014039001 V0662014036040 V0662014036039 V0662014036038 V0662014036037 V0662014036034 V0662014036030 V0662014036029 V0662014036028 V0662014036027 V0662014036025 V0662014036024 V0662014036021 V0662014036019 V0662014036018 V0662014036017 V0662014036016 V0662014036014 V0662014036011 V0662014036006 V0662014036004 V0662014036003 V0662014036002 V0662014036001 V0662014034016 V0662014034014 V0662014034010 V0662014034009 V0662014034008 V0662014034005 V0662014034004 V0662014034002 V0662014030001 V0662014029003 V0662014029002 V0662014029001 V0662014028001 V0662014027006 V0662014027004 V0662014027003 V0662014027001 V0662014025005 V0662014025004 V0662014025003 V0662014025001 V0662014024009 V0662014024008 V0662014024007 V0662014024006 V0662014024005 V0662014024004 V0662014024003 V0662014024002 V0662014024001 V0662014023008 V0662014023007 V0662014023006 V0662014023004 V0662014023002 V0662014023001 V0662014022009 V0662014022008 V0662014022006 V0662014022003 V0662014022002 V0662014022001 V0662014021011 V0662014021010 V0662014021009 V0662014021004 V0662014021001 V0662014020006 V0662014020005 V0662014020004 V0662014020003 V0662014020002 V0662014020001 V0662014017002 V0662014017001 V0662014016007 V0662014016006 V0662014016005 V0662014016004 V0662014016003 V0662014016001 V0662014015007 V0662014015006 V0662014015002 V0662014015001 V0662014014005 V0662014014003 V0662014014001 V0662014013007 V0662014013006 V0662014013004 V0662014011002 V0662014011001 V0662014010001 V0662014009003 V0662014009001 V0662014008002 V0662014007002 V0662014007001 V066201347001 V0662013354001 V0662013353012 V0662013353011 V0662013353010 V0662013353009 V0662013353007 V0662013353006 V0662013353005 V0662013353004 V0662013353003 V0662013353002 V0662013353001 V0662013352009 V0662013352008 V0662013352007 V0662013352006 V0662013352005 V0662013352004 V0662013352003 V0662013352002 V0662013352001 V0662013351005 V0662013351004 V0662013351003 V0662013351002 V0662013351001 V0662013350005 V0662013350004 V0662013350003 V0662013350002 V0662013350001 V0662013347002 V0662013347001 V0662013346003 V0662013346001 V0662013345005 V0662013345003 V0662013345002 V0662013329003 V0662013329002 V0662013329001 V0662013326005 V0662013326004 V0662013326003 V0662013326001 V0662013325002 V0662013324006 V0662013324003 V0662013323003 V0662013323002 V0662013323001 V0662013322006 V0662013322004 V0662013322001 V0662013319005 V0662013319004 V0662013319003 V0662013319002 V0662013319001 V0662013318007 V0662013318006 V0662013318004 V0662013318003 V0662013318001 V0662013317002 V0662013317001 V0662013316002 V0662013315002 V0662013315001 V0662013313001 V0662013312008 V0662013312005 V0662013312002 V0662013311006 V0662013311005 V0662013311002 V0662013310009 V0662013310007 V0662013310004 V0662013310002 V0662013309003 V0662013309002 V0662013309001 V0662013308009 V0662013308006 V0662013308005 V0662013308002 V0662013305001 V0662013304006 V0662013304005 V0662013304001 V0662013303006 V0662013303001 V0662013302006 V0662013301007 V0662013301006 V0662013301005 V0662013301004 V0662013301003 V0662013301001 V0662013298006 V0662013298004 V0662013298003 V0662013298002 V0662013298001 V0662013297007 V0662013297005 V0662013297004 V0662013297003 V0662013297002 V0662013296010 V0662013296008 V0662013296006 V0662013296005 V0662013296003 V0662013296001 V0662013295009 V0662013295008 V0662013295006 V0662013295005 V0662013295004 V0662013295002 V0662013295001 V0662013294003 V0662013294002 V0662013290005 V0662013290004 V0662013289002 V0662013289001 V0662013288003 V0662013287005 V0662013287004 V0662013287002 V0662013284002 V0662013283003 V0662013283002 V0662013282001 V0662013281006 V0662013281003 V0662013281001 V0662013277001 V0662013276003 V0662013276002 V0662013275003 V0662013275002 V0662013267005 V0662013267003 V0662013267002 V0662013267001 V0662013266006 V0662013266003 V0662013266002 V0662013263004 V0662013263003 V0662013263002 V0662013263001 V0662013262004 V0662013262002 V0662013262001 V0662013261004 V0662013261003 V0662013261002 V0662013260006 V0662013260005 V0662013259006 V0662013259004 V0662013256004 V0662013256002 V0662013256001 V0662013255004 V0662013255003 V0662013255002 V0662013255001 V0662013254003 V0662013254002 V0662013254001 V0662013253005 V0662013253004 V0662013253003 V0662013253002 V0662013253001 V0662013252004 V0662013252001 V0662013249005 V0662013249003 V0662013249002 V0662013249001 V0662013248006 V0662013248005 V0662013248004 V0662013248001 V0662013247006 V0662013247005 V0662013247003 V0662013247002 V0662013247001 V0662013246004 V0662013246003 V0662013246001 V0662013241005 V0662013241003 V0662013241002 V0662013241001 V0662013240005 V0662013240002 V0662013240001 V0662013239004 V0662013239002 V0662013239001 V0662013238001 V0662013234006 V0662013234002 V0662013234001 V0662013233005 V0662013233004 V0662013233003 V0662013233002 V0662013233001 V0662013231004 V0662013231002 V0662013231001 V0662013228005 V0662013228003 V0662013228001 V0662013227006 V0662013227005 V0662013227003 V0662013227002 V0662013227001 V0662013226008 V0662013226007 V0662013226005 V0662013226002 V0662013225005 V0662013225003 V0662013225002 V0662013224001 V0662013221003 V0662013221001 V0662013220007 V0662013220006 V0662013220005 V0662013220003 V0662013220002 V0662013220001 V0662013219005 V0662013219004 V0662013219002 V0662013218006 V0662013218004 V0662013218003 V0662013218001 V0662013217004 V0662013217002 V0662013217001 V0662013214004 V0662013214003 V0662013214001 V0662013213006 V0662013213005 V0662013213004 V0662013213003 V0662013213002 V0662013213001 V0662013212006 V0662013212005 V0662013212003 V0662013212002 V0662013212001 V0662013211007 V0662013211005 V0662013211004 V0662013211001 V0662013210009 V0662013210008 V0662013210007 V0662013210006 V0662013210004 V0662013208004 V0662013208003 V0662013207005 V0662013207004 V0662013207002 V0662013207001 V0662013206004 V0662013206003 V0662013206002 V0662013206001 V0662013205005 V0662013205003 V0662013205002 V0662013205001 V0662013204005 V0662013204004 V0662013204003 V0662013203003 V0662013203001 V0662013201002 V0662013201001 V0662013200004 V0662013200003 V0662013200002 V0662013200001 V0662013199005 V0662013199004 V0662013199003 V0662013199002 V0662013199001 V0662013198003 V0662013198001 V0662013190001 V0662013189005 V0662013189004 V0662013189002 V0662013184001 V0662013175003 V0662013175001 V0662013172002 V0662013171009 V0662013171008 V0662013171007 V0662013171006 V0662013171004 V0662013170008 V0662013170007 V0662013170002 V0662013170001 V0662013169008 V0662013169006 V0662013169005 V0662013169004 V0662013169003 V0662013168009 V0662013168008 V0662013168007 V0662013168006 V0662013168005 V0662013168004 V0662013168003 V0662013168002 V0662013168001 V0662013165004 V0662013165003 V0662013165002 V0662013164008 V0662013164007 V0662013164006 V0662013164005 V0662013164004 V0662013164003 V0662013164002 V0662013164001 V0662013163008 V0662013163003 V0662013163001 V0662013162010 V0662013162009 V0662013162008 V0662013162007 V0662013162006 V0662013162005 V0662013162004 V0662013162003 V0662013162002 V0662013161009 V0662013161005 V0662013161003 V0662013158008 V0662013158006 V0662013158005 V0662013158004 V0662013158001 V0662013157006 V0662013157005 V0662013156009 V0662013156008 V0662013156007 V0662013156005 V0662013156004 V0662013156002 V0662013155008 V0662013155005 V0662013155003 V0662013155001 V0662013154008 V0662013154007 V0662013154006 V0662013154003 V0662013154001 V0662013151006 V0662013151004 V0662013150007 V0662013150003 V0662013150002 V0662013150001 V0662013149003 V0662013148007 V0662013148005 V0662013148003 V0662013148001 V0662013144004 V0662013142005 V0662013142003 V0662013142002 V0662013142001 V0662013141007 V0662013141006 V0662013141004 V0662013141003 V0662013140006 V0662013140001 V0662013137007 V0662013137006 V0662013137005 V0662013137004 V0662013137003 V0662013137002 V0662013137001 V0662013136009 V0662013136007 V0662013136006 V0662013136004 V0662013136003 V0662013136002 V0662013136001 V0662013135007 V0662013135005 V0662013135003 V0662013135002 V0662013135001 V0662013134010 V0662013134009 V0662013134006 V0662013134005 V0662013134003 V0662013134001 V0662013133007 V0662013133006 V0662013133003 V0662013130009 V0662013130007 V0662013130006 V0662013130004 V0662013130003 V0662013130001 V0662013129007 V0662013129006 V0662013129004 V0662013129003 V0662013129001 V0662013128005 V0662013128004 V0662013128003 V0662013127010 V0662013127009 V0662013127007 V0662013127004 V0662013127003 V0662013127001 V0662013126010 V0662013126004 V0662013126001 V0662013123001 V0662013122011 V0662013122010 V0662013122007 V0662013122005 V0662013122003 V0662013122002 V0662013121008 V0662013121007 V0662013121005 V0662013121003 V0662013121001 V0662013120007 V0662013120006 V0662013120004 V0662013120003 V0662013120002 V0662013120001 V0662013119003 V0662013119002 V0662013116004 V0662013116001 V0662013115004 V0662013115003 V0662013115001 V0662013114004 V0662013114003 V0662013113007 V0662013113003 V0662013113002 V0662013112007 V0662013112006 V0662013112005 V0662013109002 V0662013108001 V0662013107009 V0662013107006 V0662013107005 V0662013107004 V0662013107003 V0662013106007 V0662013106004 V0662013105008 V0662013105007 V0662013105005 V0662013105003 V0662013105001 V0662013102003 V0662013102002 V0662013101008 V0662013101003 V0662013100008 V0662013100005 V0662013100003 V0662013099010 V0662013099008 V0662013099007 V0662013099006 V0662013099004 V0662013099003 V0662013098002 V0662013094005 V0662013093003 V0662013093002 V0662013093001 V0662013092001 V0662013087010 V0662013087007 V0662013087005 V0662013087004 V0662013087003 V0662013087002 V0662013086017 V0662013086014 V0662013086013 V0662013086012 V0662013086011 V0662013086010 V0662013086009 V0662013086008 V0662013086007 V0662013086005 V0662013086004 V0662013086003 V0662013086001 V0662013085013 V0662013085010 V0662013085009 V0662013085007 V0662013085006 V0662013085005 V0662013085003 V0662013084009 V0662013084004 V0662013084003 V0662013084002 V0662013084001 V0662013082004 V0662013082002 V0662013082001 V0662013081007 V0662013081005 V0662013081004 V0662013081003 V0662013081002 V0662013081001 V0662013080011 V0662013080007 V0662013080006 V0662013080005 V0662013080004 V0662013080001 V0662013079009 V0662013079008 V0662013079007 V0662013079005 V0662013079004 V0662013079003 V0662013079001 V0662013078012 V0662013078011 V0662013078009 V0662013078008 V0662013078006 V0662013078005 V0662013078004 V0662013078001 V0662013077009 V0662013077005 V0662013077004 V0662013077002 V0662013074003 V0662013073008 V0662013073007 V0662013073005 V0662013073002 V0662013073001 V0662013072006 V0662013072005 V0662013072004 V0662013072001 V0662013071006 V0662013071005 V0662013071003 V0662013071002 V0662013071001 V0662013070010 V0662013070009 V0662013070008 V0662013070007 V0662013070005 V0662013070004 V0662013070003 V0662013068003 V0662013068001 V0662013067011 V0662013067010 V0662013067009 V0662013067007 V0662013067003 V0662013066012 V0662013066011 V0662013066009 V0662013066008 V0662013066006 V0662013066005 V0662013066002 V0662013066001 V0662013065007 V0662013065004 V0662013064009 V0662013064008 V0662013064005 V0662013064004 V0662013064003 V0662013064002 V0662013063005 V0662013063003 V0662013063002 V0662013062003 V0662013062002 V0662013062001 V0662013061005 V0662013061004 V0662013061003 V0662013061002 V0662013061001 V0662013060006 V0662013060005 V0662013060004 V0662013060003 V0662013059006 V0662013059005 V0662013059003 V0662013059002 V0662013058010 V0662013058007 V0662013058006 V0662013058005 V0662013058004 V0662013058002 V0662013058001 V0662013057011 V0662013057010 V0662013057009 V0662013057008 V0662013057006 V0662013057005 V0662013057004 V0662013057002 V0662013057001 V0662013056011 V0662013056010 V0662013056009 V0662013056008 V0662013056006 V0662013056004 V0662013056002 V0662013056001 V0662013054010 V0662013054007 V0662013054006 V0662013054005 V0662013054004 V0662013054003 V0662013054002 V0662013054001 V0662013053010 V0662013053009 V0662013053008 V0662013053005 V0662013053001 V0662013052012 V0662013052011 V0662013052010 V0662013052004 V0662013052003 V0662013051007 V0662013051006 V0662013051003 V0662013050007 V0662013050003 V0662013050002 V0662013050001 V0662013047003 V0662013047002 V0662013047001 V0662013046004 V0662013046003 V0662013046002 V0662013045008 V0662013045007 V0662013045006 V0662013045004 V0662013045003 V0662013045001 V0662013044011 V0662013044007 V0662013044003 V0662013044002 V0662013044001 V0662013043001 V0662013042008 V0662013042007 V0662013042006 V0662013042005 V0662013042004 V0662013042003 V0662013042001 V0662013039007 V0662013039005 V0662013039003 V0662013039002 V0662013039001 V0662013038006 V0662013038005 V0662013038004 V0662013038003 V0662013038001 V0662013037008 V0662013037007 V0662013037006 V0662013037004 V0662013037003 V0662013036004 V0662013036003 V0662013036002 V0662013035006 V0662013035005 V0662013035003 V0662013035002 V0662013035001 V0662013032006 V0662013032005 V0662013032004 V0662013032003 V0662013032002 V0662013031007 V0662013031006 V0662013031005 V0662013031003 V0662013031002 V0662013029003 V0662013029002 V0662013029001 V0662013028004 V0662013028002 V0662013025004 V0662013025003 V0662013025002 V0662013025001 V0662013024004 V0662013024003 V0662013024002 V0662013024001 V0662013023002 V0662013023001 V0662013016002 V0662013015007 V0662013015003 V0662013015002 V0662013014007 V0662013014006 V0662013014004 V0662013014002 V0662013014001 V0662013011007 V0662013011005 V0662013011003 V0662013010010 V0662013010009 V0662013010008 V0662013010007 V0662013010006 V0662013009011 V0662013009009 V0662013009004 V0662013008012 V0662013007005 V0662013007004 V0662013007002 V0662012355002 V0662012353010 V0662012353009 V0662012353002 V0662012353001 V0662012352008 V0662012352007 V0662012352003 V0662012352001 V0662012349003 V0662012347012 V0662012347010 V0662012347009 V0662012347008 V0662012347005 V0662012347003 V0662012347001 V0662012346005 V0662012346003 V0662012346002 V0662012346001 V0662012345003 V0662012342005 V0662012341006 V0662012341005 V0662012341004 V0662012341001 V0662012340002 V0662012340001 V0662012335001 V0662012334001 V0662012332008 V0662012332007 V0662012332005 V0662012332002 V0662012332001 V0662012331006 V0662012331003 V0662012331001 V0662012326012 V0662012326009 V0662012326008 V0662012326007 V0662012326005 V0662012326003 V0662012325005 V0662012325004 V0662012325003 V0662012325002
Recalling Firm/
Manufacturer		 Zeltiq Aesthetics, Inc
4410 Rosewood Dr
Pleasanton CA 94588-3050
For Additional Information ContactNicole Katz
862-261-7084
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionOn 06/09/2022, the Recalling firm started sending an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx Overnight service to customers informing them discontinue and return all CoolSculpting Parallel Plate Applicators (CoolCore, CoolCurve, CoolCurve+, CoolMax, and CoolFit) due to an increase in the rate of complaints for Paradoxical hyperplasia (PH) (also referred to as Paradoxical Adipose Hyperplasia-PAH) during 2019 to 2021 timeframe. Customers are instructed to: 1. If you have the affected applicators, discontinue further use and quarantine products prior to return. 2. Monitor patients that have undergone a procedure per your normal clinical practice. . 3. Conduct a physical count of the affected applicators in your possession and record the count on the enclosed Business Response Form. 4. Send the Business Response Form to Qualanex, LLC. via fax or email within five business days of receipt. To ensure we are able to account for all recalled product, it is imperative that you return the form. Please return the Business Response Form even if no recalled product is present. 5. When returning the recalled products, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton and return the recalled product to: Qualanex, LLC. 1410 Harris Road Libertyville, IL 60048 5. Please do not return any products that are not the subject of this recall to this address. For questions or assistance, contact: Product Returns Contact Qualanex, LLC 1-800-505-9291, 7:00am - 4:00pm CST or recall@qualanex.com Adverse Events/Product Complaints Contact ZELTIQ at: 1-800-624-4261, 8am 5pm CST Medical Information Contact ZELTIQ at: 1-800-678-1605 option #2, 8:30 am 5:00 pm EST or IR-Medcom@allergan.com For after hours assistance, please leave a voicemail or email. A response will be provided within 48 hours.
Quantity in Commerce2,684 units
DistributionU.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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OOK
-
-