HeartSine Technologies Ltd recalls HeartSine SAM 350P
Reason for recall
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Lot / code information
- Model
- 350P
- Part / Item #
- 350-STR-US-10
- UDI
- code: 0506016712067
- Serial #
23D98002591E23 23D98002593E23 23D98002594E23 23D98002595E23 23D98002597E23 23D98002608E23 23D98002638E23 23D98002668E23 23D98002669E23 23D98002699E23 23D98002734E23 23D98002751E23 23D98002755E23 23D98…Show all
23D98002591E23 23D98002593E23 23D98002594E23 23D98002595E23 23D98002597E23 23D98002608E23 23D98002638E23 23D98002668E23 23D98002669E23 23D98002699E23 23D98002734E23 23D98002751E23 23D98002755E23 23D98002756E23 23D98002758E23 23D98002760E23 23D98002761E23 23D98002765E23 23D98002772E23 23D98002773E23 23D98002774E23 23D98002845E23 23D98002852E23 23D98002853E23 23D98002855E23 23D98002856E23 23D98002857E23 23D98002858E23 23D98002859E23 23D98002877E23 23D98002879E23 23D98002885E23 23D98002887E23 23D98002987E23 23D98002989E23 23D98002990E23 23D98003083E23 23D98003092E23 23D98003117I23 23D98003118E23 23D98003459D23 23D98003475D23 23D98008368E23 23D98008390E23 23D98008877E23 23D98011224D23 23D98012987E23 23D98012991E23 23D98012993E23 23D98012994E23 23D98012998E23 23D98012999E23 23D98013490F23 23D98013500F23 23D98016785E23 23D98017244E23 23D98020031C23 23D98020033C23 23D98020036C23 23D98020351C23 23D98020356C23 23D98020386C23 23D98020403C23 23D98020405C23 23D98020406C23 23D98020408C23 23D98020420C23 23D98020592D23 23D98020594D23 23D98020622D23 23D98020623D23 23D98020627D23 23D98020628D23 23D98020629D23 23D98020631D23 23D98020639D23 23D98020640D23 23D98020732D23 23D98023168E23 23D98100628I23 23D98100631I23 23D98100634I23 23D98100648I23 23D98102318K23 23D98104318J23 23D98104432J23 23D98104622J23 23D98104623J23 23D98104624J23 23D98104628J23 23D98104700J23 23D98104737J23 23D98104741J23 23D98104835J23 23D98104867J23 23D98104868J23 23D98104874J23 23D98104889J23 23D98104946J23 23D98104980J23 23D98104985J23 23D98104986J23 23D98104988J23 23D98105086J23 23D98105145J23 23D98105146J23 23D98105147J23 23D98105148J23 23D98105149J23 23D98105150J23 23D98105151J23 23D98105152J23 23D98105153K23 23D98105917J23 23D98105968J23 23D98105980J23 23D98106055J23 23D98108733I23 23D98109510I23 23D98109528I23 23D98109530I23 23D98109536I23 23D98109537I23 23D98109539I23 23D98109540I23 23D98109542I23 23D98109549I23 23D98109556I23 23D98109588I23 23D98109652I23 23D98109657I23 23D98109665I23 23D98109666I23 23D98109667I23 23D98109705I23 23D98109763I23 23D98109801I23 23D98109885I23 23D98109923I23 23D98110114I23 23D98110136I23 23D98110249I23 23D98110250I23 23D98110251I23 23D98110257I23 23D98110258I23 23D98110266I23 23D98110267I23 23D98110276I23 23D98110554H23 23D98110555H23 23D98110640H23 23D98110708H23 23D98111442K23 23D98111445K23 23D98111447K23 23D98111448K23 23D98111449K23 23D98111450K23 23D98111458K23 23D98111461K23 23D98111469K23 23D98111470K23 23D98111472K23 23D98111474K23 23D98111476K23 23D98111477K23 23D98111478K23 23D98111479K23 23D98111486K23 23D98111489K23 23D98111493K23 23D98111874I23 23D98111877I23 23D98111878I23 23D98111879I23 23D98111880I23 23D98111958I23 23D98111959I23 23D98111960I23 23D98112643G23 23D98112645G23 23D98112682G23 23D98113854H23 23D98113855H23 23D98115103H23 23D98115106H23 23D98115108H23 23D98115109H23 23D98115297H23 23D98115381H23 23D98115387H23 23D98115389H23 23D98115394H23 23D98115485H23 23D98116132G23 23D98117662G23 23D98117923I23 23D98118679G23 23D98120510I23 23D98120950I23 23D98121262J23 23D98121548J23 23D98121553J23 23D98121554J23 23D98121799J23 23D98121800J23 23D98121801J23 23D98123064I23 23D98123065I23 23D98123066I23 23D98123067I23 23D98123070I23 23D98123080I23 23D98123081I23 23D98123088I23 23D98123089I23 23D98123174I23 23D98123179I23 23D98123186I23 23D98123199I23 23D98123379I23 23D98123419I23 23D98124392J23 23D98124394J23 23D98124397J23 23D98124400J23 23D98124536J23 23D98124537J23 23D98124911J23 23D98125324H23 23D98125325H23 23D98125404H23 23D98125464I23 23D98125830G23 23D98125839G23 23D98126365G23 23D98126366G23 23D98126367G23 23D98126398G23 23D98126399G23 23D98126400G23 23D98126401G23 23D98126402G23 23D98126403G23 23D98126404G23 23D98126831J23 23D98127775H23 23D98127823H23 23D98127824H23 23D98127826H23 23D98127930H23 23D98128037H23 23D98128158K23 23D98128539H23 23D98128540H23 23D98128542H23 23D98128543H23 23D98128544H23 23D98128547H23 23D98128548H23 23D98128645H23 23D98128649H23 23D98128650H23 23D98128704H23 23D98128720H23 23D98128893H23 23D98128894H23 23D98128900H23 23D98128901H23 23D98128903H23 23D98128904H23 23D98128905H23 23D98128906H23 23D98128908H23 23D98128909H23 23D98128910H23 23D98128912H23 23D98128913H23 23D98128968H23 23D98128970H23 23D98128977H23 23D98129000H23 23D98129002H23 23D98129003H23 23D98129004H23 23D98129005H23 23D98129006H23 23D98129013H23 23D98129239H23 23D98129242H23 23D98129243H23 23D98129244H23 23D98129245H23 23D98129364H23 23D98129365H23 23D98129518H23 23D98129538H23 23D98129539H23 23D98129540H23 23D98129549H23 23D98129559H23 23D98129755H23 23D98129756H23 23D98129761H23 23D98129863H23 23D98129961H23 23D98129963H23 23D98129966H23 23D98130039H23 23D98130080H23 23D98130143H23 23D98130856H23 23D98130857H23 23D98130859H23 23D98130860H23 23D98133360H23 23D98133362H23 23D98133363H23 23D98134931H23 23D98134938H23 23D98135038H23 23D98135048H23 23D98135107H23 23D98135111H23 23D98135112H23 23D98135137H23 23D98135138H23 23D98135142H23 23D98135143H23 23D98135144H23 23D98135145H23 23D98135289H23 23D98135303H23 23D98135358H23 23D98135360H23 23D98135361H23 23D98135362H23 23D98135363H23 23D98135365H23 23D98135367H23 23D98135425H23 23D98135497H23 23D98136642H23 23D98136651H23 23D98137175K23 23D98139118I23 23D98139119I23 23D98139120I23 23D98139121I23 23D98139123I23 23D98139125I23 23D98139126I23 23D98139127I23 23D98139339J23 23D98139603J23 23D98139677I23 23D98139678I23 23D98139679I23 23D98139686I23 23D98139687I23 23D98139761I23 23D98139762I23 23D98139769I23 23D98139770I23 23D98139866I23 23D98139867I23 23D98139868I23 23D98146144K23 23D98146170K23 23D98146430K23 23D98146463K23 23D98146490K23 23D98146492K23 23D98146494K23 23D98146495K23 23D98146512K23 23D98146742K23 23D98146749K23 23D98146837K23 23D98147036K23 23D98147037K23 23D98147038K23 23D98147039K23 23D98147040K23 23D98147042K23 23D98147043K23 23D98148042J23 23D98148048J23 23D98148406J23 23D98148432J23 23D98148436J23 23D98149738K23 23D98149754K23 23D98149756K23 23D98149760K23 23D98149761K23 23D98149812K23 23D98149813K23 23D98149818K23 …- Model
- 360P
- Part / Item #
- 360-STR-US-10
- UDI
- Code: 0506016712068
- Serial #
23E90148013K23 24E90003928B24 23E90131693I23 23E90148113K23 24E90020489B24 23E90148518K23 23E90141749K23 24E90018353A24 23E90131752I23 23E90147550K23 23E90147549K23 24E90018363A24 23E90110241H23 23E90…Show all
23E90148013K23 24E90003928B24 23E90131693I23 23E90148113K23 24E90020489B24 23E90148518K23 23E90141749K23 24E90018353A24 23E90131752I23 23E90147550K23 23E90147549K23 24E90018363A24 23E90110241H23 23E90131753I23 24E90017316A24 24E90003310B24 23E90135479J23 23E90017678D23 23E90131667I23 23E90103892H23 23E90103894H23 23E90011797D23 23E90107066G23 23E90131427H23 23E90131432H23 23E90006904D23 23E90102226G23 23E90102229G23 23E90131440H23 23E90102659G23 23E90116352H23 23E90148114K23 23E90102210G23 23E90131434H23 23E90148044K23 24E90018361A24 23E90131437H23 23E90137583I23 24E90003983B24 23E90131899I23 23E90006905D23 24E90003492B24 24E90003909B24 23E90102783G23 23E90148066K23 23E90011958D23 23E90145717K23 23E90145714K23 23E90017670D23 23E90131447H23 23E90148035K23 23E90131419H23 23E90017679D23 23E90103889H23 24E90017945A24 23E90147258K23 23E90131413H23 23E90131414H23 23E90103890H23 23E90131900I23 23E90110279H23 23E90131420H23 23E90131896I23 23E90131898I23 23E90131895I23 23E90110826H23 23E90110828H23 23E90110832H23 23E90131438H23 23E90131389H23 23E90107138G23 24E90003893B24 24E90018362A24 24E90017657A24 24E90017483A24 24E90018364A24 23E90110244H23 23E90131748I23 23E90131768I23 23E90011792D23 23E90131904I23 23E90148045K23 23E90107042G23 23E90131448H23 23E90139250I23 24E90018369A24 23E90105485F23 23E90102232G23 23E90107065G23 23E90107068G23 23E90145869K23 23E90145523K23 23E90145475K23 23E90145500K23 23E90102169G23 23E90110286H23 23E90131750I23 23E90131435H23 23E90131431H23 23E90145612K23 23E90147674K23 23E90145484K23 23E90102339G23 23E90130517J23 23E90144000K23 23E90147651K23 23E90145853K23 23E90145852K23 23E90145850K23 24E90017311A24 23E90148014K23 23E90145540K23 23E90006926D23 23E90004982D23 23E90006886D23 23E90006971D23 23E90004978D23 23E90004984D23 23E90006885D23 23E90006964D23 23E90004981D23 23E90006961D23 23E90004983D23 23E90006890D23 23E90006866D23 23E90006910D23 23E90006880D23 23E90004979D23 23E90006970D23 23E90006962D23 23E90006863D23 23E90006968D23 23E90006879D23 23E90006878D23 23E90006884D23 23E90006892D23 23E90006864D23 23E90006903D23 23E90006891D23 23E90006889D23 23E90006893D23 23E90006972D23 23E90006973D23 23E90006907D23 23E90006868D23 23E90006966D23 23E90006930D23 23E90006969D23 23E90006814D23 23E90006815D23 23E90006817D23 23E90006816D23 23E90006813D23 23E90017627D23 23E90017634D23 23E90017628D23 23E90017632D23 23E90017624D23 23E90017636D23 23E90017631D23 23E90017394D23 23E90017735D23 23E90017677D23 23E90017734D23 23E90017392D23 23E90017637D23 23E90017676D23 23E90017674D23 23E90017672D23 23E90017731D23 23E90017675D23 23E90017393D23 23E90017396D23 23E90017395D23 23E90017381D23 23E90017384D23 23E90017382D23 23E90017383D23- Model
- 450P
- Part / Item #
- 450-STR-US-10
- UDI
- code: 0506016712069
- Serial #
23G90001569G23 24G90012089B24 24G90012094B24 24G90012120B24 24G90012118B24 23G90006184D23 23G90009052H23 23G90106476K23 23G90006183D23 23G90106676K23 23G90103796J23 23G90003902H23 23G90105515K23 23G90…Show all
23G90001569G23 24G90012089B24 24G90012094B24 24G90012120B24 24G90012118B24 23G90006184D23 23G90009052H23 23G90106476K23 23G90006183D23 23G90106676K23 23G90103796J23 23G90003902H23 23G90105515K23 23G90106520K23 23G90106492K23 24G90011087B24 24G90011095B24 23G90107201J23 23G90112607I23 23G90006018D23 23G90105531K23 23G90105573K23 24G90011227B24 23G90110119I23 23G90106011K23 23G90100686K23 23G90106451K23 23G90102992K23 23G90106454K23 23G90106450K23 23G90110201I23 23G90110231I23 23G90100180K23 23G90009404H23 23G90009087H23 23G90009081H23 23G90105399K23 24G90015878A24 23G90008758G23 23G90007502E23 23G90107962K23 23G90102997K23 24G90015874A24 23G90107191J23 23G90107190J23 23G90107195J23 23G90102586J23 23G90107957K23 23G90107393J23 23G90106336K23 23G90008501G23 23G90105667K23 23G90102993K23 23G90106219K23 23G90107945K23 23G90107939K23 23G90112605I23 23G90112599I23 23G90110351I23 23G90110352I23 23G90110348I23 23G90110410I23 23G90112592I23 23G90110127I23 23G90102297K23 24G90016931B24 23G90100548K23 23G90106720K23 24G90015868A24 23G90106449K23 23G90106442K23 23G90106593K23 23G90106591K23 23G90100684K23 23G90106258K23 23G90106261K23 23G90000087H23 23G90000388H23 23G90106033K23 23G90105574K23 23G90110355I23 23G90008634G23 23G90009577H23 23G90109116J23 24G90008247D24 23G90106617K23 23G90106612K23 23G90106619K23 23G90106616K23 23G90106610K23 23G90106601K23 23G90100661K23 23G90100550K23 23G90106684K23 23G90106689K23 23G90101190L23 23G90106645K23 23G90109102J23 23G90106238K23 23G90109029J23 23G90109096J23 23G90105721K23 23G90000296H23 23G90102987K23 23G90003942H23 23G90101215L23 23G90107607J23 23G90107606J23 24G90011267B24 23G90006044D23 23G90112597I23 23G90009414H23 23G90107387J23 23G90107392J23 23G90109373L23 23G90109464L23 23G90107605J23 23G90106830K23 23G90103685L23 23G90101191L23 23G90109047J23 23G90001557G23 23G90001499I23 23G90008538G23 23G90006616G23 24G90001625D24 23G90008434G23 23G90008503G23 23G90008498G23 23G90008435G23 23G90008499G23 23G90008500G23 23G90008436G23 23G90008438G23 23G90008504G23 23G90000094H23 23G90001498I23 23G90112676I23 23G90110125I23 23G90110124I23 23G90112596I23 23G90001698L23 23G90008129L23 24G90011961B24 24G90011770B24 24G90016892B24 24G90001627D24 23G90112598I23 24G90011079B24 24G90011084B24 23G90106377K23 23G90105518K23 23G90105514K23 23G90103206J23 23G90107343J23 23G90107340J23 23G90110088I23 23G90106170K23 23G90108000K23 23G90106543K23 23G90107908K23 24G90001615D24 23G90000420H23 23G90000059H23 23G90000444H23 24G90011800B24 24G90011772B24 23G90004018G23 23G90106446K23 23G90112726L23 23G90105202K23 23G90008540G23 23G90106832K23 24G90001596D24 23G90108251L23 23G90106448K23 23G90109051J23 23G90109084J23 23G90106058K23 23G90107476J23 23G90109083J23 23G90109258J23 23G90109257J23 23G90109250J23 23G90109254J23 23G90109216J23 23G90109207J23 23G90109200J23 23G90109227J23 23G90109226J23 24G90012061B24 23G90109199J23 23G90109036J23 23G90110090I23 23G90008548G23 24G90001607D24 23G90105720K23 23G90110034I23 23G90105258K23 23G90008403G23 24G90011081B24 23G90105835L23 23G90006066D23 23G90006014D23 23G90006117D23 23G90008716G23 23G90008717G23 23G90009068H23 23G90107923K23 23G90102623L23 23G90106197K23 23G90110130I23 23G90001497I23 23G90110202I23 23G90009050H23 23G90107344J23 23G90106103K23 23G90106109K23 23G90001666G23 23G90106515K23 23G90106522K23 23G90100798L23 23G90109035J23 23G90112600I23 23G90004216G23 23G90001500I23 24G90012965H24 23G90102978J23 23G90109238J23 23G90004473G23 23G90009069H23 23G90009031H23 23G90109014J23 23G90008394G23 24G90001554D24 24G90001645D24 24G90012121B24 23G90106244K23 23G90109259J23 23G90006110D23 23G90006143D23 23G90006107D23 23G90105713K23 23G90107663J23 23G90100558K23 24G90009715D24 23G90009592H23 23G90000203H23 23G90009083H23 23G90108632L23 23G90110235I23 23G90107638J23 23G90107640J23 23G90106523K23 23G90004376G23 23G90100722L23 23G90106474K23 23G90106479K23 23G90108013L23 23G90108014L23 23G90108008L23 23G90108007L23 23G90106200K23 23G90101196L23 23G90110198I23 23G90105741K23 23G90000206H23 24G90016907B24 23G90109465J23 23G90008413G23 23G90105534K23 23G90105580K23 23G90106095K23 23G90009036H23 23G90009049H23 23G90106036K23 24G90011798B24 23G90107931K23 24G90011807B24 24G90011537B24 23G90103826J23 23G90103793J23 23G90105519K23 23G90000360L23 23G90008043L23 23G90102681L23 23G90102423L23 23G90105198K23 23G90105194K23 23G90106070K23 23G90106150L23 24G90011086B24 23G90107671J23 23G90001483I23 23G90110099I23 23G90000399H23 23G90110055I23 23G90101155L23 23G90110039I23 23G90110154I23 23G90110023I23 23G90001478I23 23G90110350I23 23G90109094J23 23G90109081J23 23G90109111J23 23G90105646K23 23G90110224I23 24G90011532B24 23G90105712K23 23G90107398J23 23G90001494I23 23G90109107J23 23G90106142K23 23G90109109J23 23G90008888G23 23G90106253K23 23G90106256K23 23G90001486I23 23G90107482J23 23G90008405G23 23G90106105K23 23G90112606I23 23G90112608I23 23G90107964K23 23G90109261J23 23G90109077J23 23G90109112J23 23G90109046J23 23G90103827J23 23G90108460L23 23G90106799K23 23G90106831K23 23G90105861L23 23G90107346J23 23G90103818J23 23G90009576H23 23G90009590H23 23G90106169K23 23G90107966K23 23G90106117K23 23G90100707K23 23G90105760K23 23G90106273K23 23G90106537K23 24G90011089B24 24G90011091B24 24G90011093B24 23G90004436L23 23G90004214L23 23G90004385L23 23G90108277L23 23G90110094I23 23G90110205I23 23G90110206I23 23G90000301H23 23G90110397I23 23G90106084K23 24G90011193B24 24G90011190B24 24G90011007B24 24G90011000B24 24G90010996B24 24G90011001B24 24G90011002B24 24G90011332B24 24G90010986B24 24G90011310B24 24G90011283B24 24G90011311B24 24G90011312B24 24G90011313B24 24G90017211B24 24G90011307B24 24G90011309B24 24G90011185B24 24G90011182B24 24G90011180B24 24G90011181B24 24G90011178B24 24G90011329B24 24G90011334B24 24G90011284B24 24G90011288B24 24G90011285B24 24G90011316B24 24G90011287B24 24G90011071B24 24G90011299B24 24G90011297B24 24G90011015B24 24G90011301B24 24G90011014B24 24G90011008B24 24G90017232B24 24G90011296B24 24G90011303B24 24G90011300B24 24G90011304B24 24G90011027B24 …- Model
- 350P
- Part / Item #
- 350-STR-US-AV
- UDI
- Code: 0506016712070
- Serial #
- 23D98134849H23 23D98134643G23 23D98134836H23 23D98134853H23 23D98134648G23
- Model
- 350P
- Part / Item #
- 350-STR-US-GW
- UDI
- code: 05060167128042
- Serial #
- 23D98132720G23 23D98132737G23 23D98132729G23 23D98132727G23 24D98033686E24 23D98117696G23 23D98117713G23 23D98117710G23 23D98117712G23
- Model
- 360P
- Part / Item #
- 360-STR-US-GW
- UDI
- code: 0506016712806
- Serial #
- 23E90110301H23 23E90110018H23
- Model
- 450P
- Part / Item #
- 450-STR-US-GW
- UDI
- code: 0506016712808
- Serial #
- 23G90004884G23 23G90004340G23 Pending O.U.S. Product Information (note information below is both U.S. and O.U.S. information ***************************************** Sales Code /
- GTIN
- Code: 350-BAC-BZ-10 0506016712235
- Serial #
23D90000147 23D90000149 23D90000151 23D90000152 23D90000153 23D90000154 23D90000171 23D90000172 23D90000173 23D90000174 23D90000175 23D90000176 23D90000177 23D90000178 23D90000182 23D90000019 23D90000…Show all
23D90000147 23D90000149 23D90000151 23D90000152 23D90000153 23D90000154 23D90000171 23D90000172 23D90000173 23D90000174 23D90000175 23D90000176 23D90000177 23D90000178 23D90000182 23D90000019 23D90000020 23D90000021 23D90000022 23D90000023 23D90000024 23D90000025 23D90000026 23D90000035 23D90000036 23D90000037 23D90000038 23D90000039 23D90000040 23D90000041 23D90000042 23D90000043 23D90000044 23D90000050 23D90000052 23D90000123 23D90000124 23D90000125 23D90000126 23D90000127 23D90000128 23D90000129 23D90000130 23D90000129 23D90000177 23D90000182 23D91000026 23D91000027 23D91000028 23D91000011 23D91000012 23D91000013 23D91000014 23D91000015 23D91000024 23D91000025 23D91000008 23D91000009 23D91000010 23D91000016 23D91000017 23D91000018 23D91000019 23D91000020 23D91000021 23D91000022 23D91000023 Sales Code /- GTIN
- Code: 350-BAS-AS-10 /
- Serial #
23D98000921L23 23D98003683F23 23D98007722E23 23D98017029F23 23D98017354F23 23D98024610F23 23D98024820F23 23D98133501F23 23D98133502F23 23D98133748F23 23D98133749F23 23D98133750F23 23D98133751F23 23D98…Show all
23D98000921L23 23D98003683F23 23D98007722E23 23D98017029F23 23D98017354F23 23D98024610F23 23D98024820F23 23D98133501F23 23D98133502F23 23D98133748F23 23D98133749F23 23D98133750F23 23D98133751F23 23D98133752F23 23D98133753F23 23D98133754F23 23D98133755F23 23D98133756F23 23D98133759F23 23D98133760F23 23D98133761F23 23D98133762F23 23D98133763F23 23D98133764F23 23D98133765F23 23D98133766F23 23D98133767F23 23D98141094B24 23D98141111B24 23D98145914J23 23D98145915J23 23D98145916J23 24D98027738D24 24D98027739D24 24D98027740D24 24D98027741D24 24D98027742D24 24D98027743D24 24D98027744D24 24D98027745D24 24D98027746D24 24D98027747D24 24D98027748D24 24D98027749D24 24D98027750D24 24D98027751D24 24D98027752D24 24D98027753D24 24D98027754D24 24D98027755D24 24D98027756D24 24D98027757D24 24D98027758D24 24D98027759D24 24D98027760D24 24D98027761D24 24D98027762D24 24D98027763D24 24D98027764D24 24D98027765D24 24D98027766D24 24D98027767D24 24D98027768D24 24D98027769D24 24D98027770D24 24D98027771D24 24D98027772D24 24D98027773D24 24D98027774D24 24D98027775D24 24D98027776D24 24D98027777D24 24D98027778D24 24D98027779D24 24D98027780D24 24D98027781D24 24D98027782D24 24D98027783D24 24D98027784D24 24D98027785D24 24D98027786D24 24D98027787D24 24D98027788D24 24D98027789D24 24D98027790D24 24D98027791D24 24D98027792D24 24D98027793D24 24D98027794D24 24D98027795D24 24D98027796D24 24D98027797D24 24D98027798D24 24D98027799D24 24D98029990B24 24D98034126A24 24D98034127A24 24D98034128A24 24D98034129A24 24D98034130A24 24D98034135A24 24D98034137A24 24D98034138A24 24D98034141A24 24D98034143A24 24D98034145A24 24D98034146A24 24D98034147A24 24D98034148A24 24D98034151A24 24D98034153A24 24D98034156A24 24D98034157A24 24D98034158A24 24D98034159A24 24D98034160A24 24D98034176A24 24D98034177A24 24D98034178A24 24D98034226A24 24D98034227A24 24D98034228A24 24D98034230A24 24D98034232A24 24D98034233A24 24D98034234A24 24D98034235A24 24D98034236A24 24D98034237A24 24D98034238A24 24D98034241A24 24D98034242A24 24D98034246A24 24D98034247A24 24D98034248A24 24D98034252A24 24D98034256A24 24D98034258A24 24D98034259A24 24D98034260A24 24D98034261A24 24D98034265A24 24D98034266A24 24D98034267A24 24D98034268A24 24D98034269A24 24D98034270A24 24D98034271A24 24D98034272A24 24D98034273A24 24D98034274A24 24D98034275A24 24D98047291B24 Sales Code /- GTIN
- Code: 350-BAS-AB-10 0506016712473 Sales Code /
- GTIN
- Code: 350-BAS-AS-10 0506016712137
- Serial #
23D98000921L23 23D98003683F23 23D98007722E23 23D98017029F23 23D98017354F23 23D98024610F23 23D98024820F23 23D98133501F23 23D98133502F23 23D98133748F23 23D98133749F23 23D98133750F23 23D98133751F23 23D98…Show all
23D98000921L23 23D98003683F23 23D98007722E23 23D98017029F23 23D98017354F23 23D98024610F23 23D98024820F23 23D98133501F23 23D98133502F23 23D98133748F23 23D98133749F23 23D98133750F23 23D98133751F23 23D98133752F23 23D98133753F23 23D98133754F23 23D98133755F23 23D98133756F23 23D98133759F23 23D98133760F23 23D98133761F23 23D98133762F23 23D98133763F23 23D98133764F23 23D98133765F23 23D98133766F23 23D98133767F23 23D98141094B24 23D98141111B24 23D98145914J23 23D98145915J23 23D98145916J23 24D98027738D24 24D98027739D24 24D98027740D24 24D98027741D24 24D98027742D24 24D98027743D24 24D98027744D24 24D98027745D24 24D98027746D24 24D98027747D24 24D98027748D24 24D98027749D24 24D98027750D24 24D98027751D24 24D98027752D24 24D98027753D24 24D98027754D24 24D98027755D24 24D98027756D24 24D98027757D24 24D98027758D24 24D98027759D24 24D98027760D24 24D98027761D24 24D98027762D24 24D98027763D24 24D98027764D24 24D98027765D24 24D98027766D24 24D98027767D24 24D98027768D24 24D98027769D24 24D98027770D24 24D98027771D24 24D98027772D24 24D98027773D24 24D98027774D24 24D98027775D24 24D98027776D24 24D98027777D24 24D98027778D24 24D98027779D24 24D98027780D24 24D98027781D24 24D98027782D24 24D98027783D24 24D98027784D24 24D98027785D24 24D98027786D24 24D98027787D24 24D98027788D24 24D98027789D24 24D98027790D24 24D98027791D24 24D98027792D24 24D98027793D24 24D98027794D24 24D98027795D24 24D98027796D24 24D98027797D24 24D98027798D24 24D98027799D24 24D98029990B24 24D98034126A24 24D98034127A24 24D98034128A24 24D98034129A24 24D98034130A24 24D98034135A24 24D98034137A24 24D98034138A24 24D98034141A24 24D98034143A24 24D98034145A24 24D98034146A24 24D98034147A24 24D98034148A24 24D98034151A24 24D98034153A24 24D98034156A24 24D98034157A24 24D98034158A24 24D98034159A24 24D98034160A24 24D98034176A24 24D98034177A24 24D98034178A24 24D98034226A24 24D98034227A24 24D98034228A24 24D98034230A24 24D98034232A24 24D98034233A24 24D98034234A24 24D98034235A24 24D98034236A24 24D98034237A24 24D98034238A24 24D98034241A24 24D98034242A24 24D98034246A24 24D98034247A24 24D98034248A24 24D98034252A24 24D98034256A24 24D98034258A24 24D98034259A24 24D98034260A24 24D98034261A24 24D98034265A24 24D98034266A24 24D98034267A24 24D98034268A24 24D98034269A24 24D98034270A24 24D98034271A24 24D98034272A24 24D98034273A24 24D98034274A24 24D98034275A24 24D98047291B24 Sales Code /- GTIN
- Code: 350-BAS-AS-GW 0506016712970 350-BAS-BZ-10 0506016712138 350-BAS-CF-10 0506016712474
- Serial #
- 23D98010039K23 23D98010260K23 23D98109393I23 23D98113071I23 23D98113491I23 23D98113502I23 23D98117269I23 24D98065981E24 24D98065989E24 Sales Code /
- GTIN
- Code: 350-BAS-CN-10 0506016712159
- Serial #
23D98015400J23 23D98016300J23 23D98017373E23 23D98017374E23 23D98017375E23 23D98017376E23 23D98017377E23 23D98017378E23 23D98017379E23 23D98017380E23 23D98017381E23 23D98017382E23 23D98017383E23 23D98…Show all
23D98015400J23 23D98016300J23 23D98017373E23 23D98017374E23 23D98017375E23 23D98017376E23 23D98017377E23 23D98017378E23 23D98017379E23 23D98017380E23 23D98017381E23 23D98017382E23 23D98017383E23 23D98017384E23 23D98017385E23 23D98017386E23 23D98017387E23 23D98017389E23 23D98017390E23 23D98017391E23 23D98017392E23 23D98017393E23 23D98017394E23 23D98017395E23 23D98017396E23 23D98017397E23 23D98017398E23 23D98017401E23 23D98017402E23 23D98017403E23 23D98017404E23 23D98017405E23 23D98017406E23 23D98017407E23 23D98017408E23 23D98017409E23 23D98017410E23 23D98019800E23 23D98019801E23 23D98019803E23 23D98019804E23 23D98019805E23 23D98019897E23 23D98021110J23 23D98021134J23 23D98105331J23 23D98105332J23 23D98105333J23 23D98105334J23 23D98105335J23 23D98105336J23 23D98105337J23 23D98105338J23 23D98105339J23 23D98105341J23 23D98105342J23 23D98105343J23 23D98105344J23 23D98105345J23 23D98105346J23 23D98105347J23 23D98105348J23 23D98105349J23 23D98105351J23 23D98105352J23 23D98105353J23 23D98105355J23 23D98105356J23 23D98105357J23 23D98105358J23 23D98105359J23 23D98105360J23 23D98105361J23 23D98105362J23 23D98105363J23 23D98105364J23 23D98105365J23 23D98105366J23 23D98105367J23 23D98105368J23 23D98105369J23 23D98105370J23 23D98105372J23 23D98105373J23 23D98105374J23 23D98105375J23 23D98105376J23 23D98105377J23 23D98105378J23 23D98105429J23 23D98105430J23 23D98105431J23 23D98105432J23 23D98105433J23 23D98105434J23 23D98105435J23 23D98105436J23 23D98105437J23 23D98105438J23 23D98106382J23 23D98106383J23 23D98106384J23 23D98106385J23 23D98106386J23 23D98110557H23 23D98110558H23 23D98110559H23 23D98110560H23 23D98110561H23 23D98110562H23 23D98110563H23 23D98110564H23 23D98110565H23 23D98110566H23 23D98110567H23 23D98110568H23 23D98110569H23 23D98110570H23 23D98110571H23 23D98110572H23 23D98110573H23 23D98110574H23 23D98110575H23 23D98110577H23 23D98110578H23 23D98110579H23 23D98110580H23 23D98110581H23 23D98110582H23 23D98110583H23 23D98110584H23 23D98110585H23 23D98113483H23 23D98117938J23 23D98117939J23 23D98117940J23 23D98117941J23 23D98117942J23 23D98117943J23 23D98117944J23 23D98117945J23 23D98117946J23 23D98117947J23 23D98117948J23 23D98117949J23 23D98117950J23 23D98117951J23 23D98117952J23 23D98117953J23 23D98117954J23 23D98117955J23 23D98117956J23 23D98117957J23 23D98117958J23 23D98117959J23 23D98117960J23 23D98117961J23 23D98119093J23 23D98119094J23 23D98119112J23 23D98119135J23 23D98119136J23 23D98119137J23 23D98119138J23 23D98119139J23 23D98119140J23 23D98119141J23 23D98119142J23 23D98119143J23 23D98119144J23 23D98119145J23 23D98119146J23 23D98119147J23 23D98119148J23 23D98119149J23 23D98119150J23 23D98120241I23 23D98120242I23 23D98120243I23 23D98120244I23 23D98120245I23 23D98120246I23 23D98120247I23 23D98120248I23 23D98120249I23 23D98120250I23 23D98120251I23 23D98120252I23 23D98120253I23 23D98120254I23 23D98120255I23 23D98120256I23 23D98120257I23 23D98120258I23 23D98120259I23 23D98120260I23 23D98120261I23 23D98120262I23 23D98120263I23 23D98120264I23 23D98120265I23 23D98120266I23 23D98120267I23 23D98120268I23 23D98120269I23 23D98120270I23 23D98120271I23 23D98120272I23 23D98120273I23 23D98120274I23 23D98120275I23 23D98120276I23 23D98120277I23 23D98120278I23 23D98120279I23 23D98120280I23 23D98120281I23 23D98120282I23 23D98120283I23 23D98120284I23 23D98120285I23 23D98120286I23 23D98120287I23 23D98120288I23 23D98120289I23 23D98120290I23 23D98120291I23 23D98120292I23 23D98120293I23 23D98120294I23 23D98120295I23 23D98120296I23 23D98120297I23 23D98120298I23 23D98120299I23 23D98120300I23 23D98120301I23 23D98120316I23 23D98120318I23 23D98120319I23 23D98120320I23 23D98120321I23 23D98120322I23 23D98120323I23 23D98120325I23 23D98120326I23 23D98120327I23 23D98120328I23 23D98120329I23 23D98120330I23 23D98120331I23 23D98120332I23 23D98120333I23 23D98120334I23 23D98120335I23 23D98120336I23 23D98120337I23 23D98120338I23 23D98120339I23 23D98120340I23 23D98120341I23 23D98120342I23 23D98120343I23 23D98120344I23 23D98120345I23 23D98120346I23 23D98120347I23 23D98120348I23 23D98120349I23 23D98120350I23 23D98120351I23 23D98120352I23 23D9812
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Additional code information
0353I23 23D98120354I23 23D98120355I23 23D98120356I23 23D98120357I23 23D98120358I23 23D98120359I23 23D98120360I23 23D98120361I23 23D98120362I23 23D98120363I23 23D98120364I23 23D98120365I23 23D98120366I23 23D98120367I23 23D98120368I23 23D98120369I23 23D98120370I23 23D98120371I23 23D98120372I23 23D98120373I23 23D98120374I23 23D98120375I23 23D98120376I23 23D98120377I23 23D98120378I23 23D98120379I23 23D98120380I23 23D98120381I23 23D98120382I23 23D98120383I23 23D98120384I23 23D98120385I23 23D98120386I23 23D98120387I23 23D98120388I23 23D98120389I23 23D98120390I23 23D98120391I23 23D98120589I23 23D98120606I23 23D98120607I23 23D98120608I23 23D98120609I23 23D98120610I23 23D98120611I23 23D98120613I23 23D98120614I23 23D98120616I23 23D98120618I23 23D98120619I23 23D98120620I23 23D98120621I23 23D98120622I23 23D98120624I23 23D98120626I23 23D98120627I23 23D98120628I23 23D98120629I23 23D98120630I23 23D98120631I23 23D98120632I23 23D98120633I23 23D98120634I23 23D98120635I23 23D98120637I23 23D98120638I23 23D98120639I23 23D98120640I23 23D98120641I23 23D98120642I23 23D98120676I23 23D98120677I23 23D98120678I23 23D98120679I23 23D98120680I23 23D98120681I23 23D98120682I23 23D98120683I23 23D98120684I23 23D98120685I23 23D98120686I23 23D98120687I23 23D98120688I23 23D98120689I23 23D98120690I23 23D98120691I23 23D98120693I23 23D98120694I23 23D98120696I23 23D98120697I23 23D98120698I23 23D98120699I23 23D98120700I23 23D98120701I23 23D98120702I23 23D98120703I23 23D98120704I23 23D98120705I23 23D98120706I23 23D98123001I23 23D98123002I23 23D98123003I23 23D98123005I23 23D98123006I23 23D98123007I23 23D98123008I23 23D98123009I23 23D98123010I23 23D98123011I23 23D98123012I23 23D98123013I23 23D98123014I23 23D98123015I23 23D98123016I23 23D98123018I23 23D98123019I23 23D98123020I23 23D98123021I23 23D98123022I23 23D98123023I23 23D98123024I23 23D98123025I23 23D98123026I23 23D98123027I23 23D98123028I23 23D98123029I23 23D98123030I23 23D98123031I23 23D98125586F23 23D98125587F23 23D98125588F23 23D98125589F23 23D98125590F23 23D98125591F23 23D98125592F23 23D98125593F23 23D98125594F23 23D98125595F23 23D98125596F23 23D98125597F23 23D98125598F23 23D98125599F23 23D98125600F23 23D98125601F23 23D98131056H23 23D98131057H23 23D98131058H23 23D98131059H23 23D98131060H23 23D98131061H23 23D98131062H23 23D98131063H23 23D98131064H23 23D98131065H23 23D98131066H23 23D98131067H23 23D98131068H23 23D98131069H23 23D98131071H23 23D98131072H23 23D98131073H23 23D98131074H23 23D98131075H23 23D98131076H23 23D98131077H23 23D98131078H23 23D98131079H23 23D98131080H23 23D98131081H23 23D98131082H23 23D98131083H23 23D98131084H23 23D98131085H23 23D98131086H23 23D98131088H23 23D98131089H23 23D98131090H23 23D98131091H23 23D98131092H23 23D98131093H23 23D98131094H23 23D98131095H23 23D98131096H23 23D98131098H23 23D98131099H23 23D98131100H23 23D98131101H23 23D98131102H23 23D98131103H23 23D98131104H23 23D98131156H23 23D98131157H23 23D98131158H23 23D98131159H23 23D98131160H23 23D98131161H23 23D98131162H23 23D98131163H23 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What the firm is doing
On 06/30/2025, the firm sent via USPS First Class an "URGENT: MEDICAL device recall" Letter to customers informing them Stryker has determined that for the HeartSine samaritan PAD, a manufacturing process issue related to a circuit board component may impair the device's ability to function or cause failure. This failure could occur at any point when the device is holding a charge in preparation to deliver therapy, while delivering a shock, or after shock delivery. The device becomes inoperable after the failure occurs. Customer are instructed to: 1. Identify impacted devices by verifying if their device serial numbers are included in the list at the link https://www.stryker.com/us/en/emergency-care/product-notice/heartsine/index.html 2. Submit customer response electronically via the QR code scan or link https://bit.ly/fa318-heartsine, or response via email to: RSRecall@stryker.com and include the following Subject: FA 318 HeartSine T3 - Response from <<>> Email Body: -Customer ID, Customer Name, title and email address -The number of devices impacted by model, and serial numbers -Provide if any devices have been further distributed 3. Until a replacement is available, Stryker recommends keeping HeartSine device in service if there is no alternative public access defibrillator. For questions or concerns, contact Stryker Customer at +1 800-787-9537, option 2 from 8:00 AM to 7:00 PM (Eastern Time) Monday thru Friday or contact Technical Support at heartsinesupport@stryker.com
DistributionShow detailsHide
Worldwide - U.S. Nationwide distribution including in the states of 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Austria, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Hong Kong, Indonesia, Ireland, Israel, Japan, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Poland, Singapore, South Korea, Taiwan, Thailand, and United Kingdom.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2174-2025
- FDA device classification · MKJOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.5310The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find HeartSine Technologies LtdSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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