{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "218886",
      "product_res_number": "Z-3270-2026",
      "event_date_initiated": "2026-07-27",
      "event_date_posted": "2026-09-25",
      "recall_status": "Open, Classified",
      "res_event_number": "98483",
      "product_code": "MKJ",
      "pma_numbers": [
        "P160008"
      ],
      "product_description": "HeartSine samaritan PAD (Public Access Defibrillator); \r\nHeartSine SAM 350P \r\n350P US Device, US English - 2 Min CPR \r\nUDI-DI codes: 0506016712067  \r\n350P US Device, US English (American Airlines) - 2 Min CPR \r\nUDI-DI code: 0506016712207  \r\n350P US Device, US English with Gateway - 2 Min CPR \r\nUDI-DI code: 0506016712804  \r\n\r\nHeartSine SAM 360P \r\n360P US Device, US English - 2 Min CPR \r\nUDI-DI code: 0506016712068  \r\n\r\nHeartSine SAM 450P \r\nSAM 450P   US Device, US English (2 min CPR) \r\nUDI-DI code: 0506016712069",
      "code_info": "Product - 350P US Device, US English - 2 Min CPR\nItem code: 350-STR-US-10\nUDI-DI code: 0506016712067\nSerial Numbers:\n24D98056051D24\n24D98057467D24\n24D98057468D24\n24D98057469D24\n24D98068091E24\n24D98068097E24\n24D98070022F24\n24D98070023F24\n24D98070024F24\n24D98070025F24\n24D98070026F24\n24D98070027F24\n24D98070028F24\n24D98070029F24\n24D98070030F24\n24D98070031F24\n24D98070032F24\n24D98070033F24\n24D98070034F24\n24D98070035F24\n24D98070036F24\n24D98070037F24\n24D98070038F24\n24D98070040F24\n24D98070041F24\n24D98070042F24\n24D98070043F24\n24D98070046F24\n24D98070047F24\n24D98070048F24\n24D98070049F24\n24D98070050F24\n24D98070051F24\n24D98070052F24\n24D98070053F24\n24D98070054F24\n24D98070055F24\n24D98070056F24\n24D98070057F24\n24D98070058F24\n24D98070060F24\n24D98070061F24\n24D98070062F24\n24D98070063F24\n24D98070064F24\n24D98070065F24\n24D98070066F24\n24D98070068F24\n24D98070069F24\n24D98070071F24\n24D98070072F24\n24D98070074F24\n24D98070075F24\n24D98070076F24\n24D98070077F24\n24D98070078F24\n24D98070079F24\n24D98070080F24\n24D98070081F24\n24D98070082F24\n24D98070083F24\n24D98070084F24\n24D98070085F24\n24D98070087F24\n24D98070088F24\n24D98070089F24\n24D98070091F24\n24D98070092F24\n24D98070093F24\n24D98070094F24\n24D98070095F24\n24D98070096F24\n24D98070097F24\n24D98070100F24\n24D98070102F24\n24D98070103F24\n24D98070104F24\n24D98070107F24\n24D98070108F24\n24D98070109F24\n24D98070110F24\n24D98070111F24\n24D98070114F24\n24D98070115F24\n24D98070117F24\n24D98070118F24\n24D98070119F24\n24D98070120F24\n24D98070121F24\n24D98070122F24\n24D98070123F24\n24D98070126F24\n24D98070127F24\n24D98070128F24\n24D98070129F24\n24D98070130F24\n24D98070132F24\n24D98070133F24\n24D98070134F24\n24D98070135F24\n24D98070136F24\n24D98070138F24\n24D98070139F24\n24D98070140F24\n24D98070141F24\n24D98070143F24\n24D98070144F24\n24D98070145F24\n24D98070148F24\n24D98070149F24\n24D98070150F24\n24D98070151F24\n24D98070157F24\n24D98070160F24\n24D98070161F24\n24D98070162F24\n24D98070163F24\n24D98070166F24\n24D98056785D24\n24D98057279D24\n24D98057648D24\n24D98053900E24\n24D98054669E24\n24D98054543E24\n24D98054034E24\n24D98050678E24\n24D98050536E24\n24D98055040E24\n24D98055328E24\n24D98050945E24\n24D98055733E24\n24D98070147F24\n24D98070039F24\n24D98070101F24\n24D98070105F24\n24D98070146F24\n24D98070045F24\n24D98070067F24\n24D98070116F24\n24D98070099F24\n24D98070044F24\n24D98070098F24\n24D98070059F24\n24D98070073F24\n24D98070090F24\n24D98070142F24\n24D98070124F24\n24D98070113F24\n24D98070131F24\n24D98070112F24\n24D98070125F24\n24D98070412F24\n24D98026634F24\n24D98026619F24\n24D98048208F24\n24D98026934F24\n24D98026936F24\n24D98048576F24\n24D98048559F24\n24D98048502F24\n24D98048594F24\n24D98048571F24\n24D98048600F24\n24D98048566F24\n24D98048609F24\n24D98048588F24\n24D98048578F24\n24D98048554F24\n24D98048499F24\n24D98048503F24\n24D98048504F24\n24D98048574F24\n24D98048582F24\n24D98048491F24\n24D98048556F24\n24D98048597F24\n24D98048598F24\n24D98048570F24\n24D98048712F24\n24D98048560F24\n24D98048500F24\n24D98048595F24\n24D98048575F24\n24D98048709F24\n24D98048603F24\n24D98048495F24\n24D98048617F24\n24D98048492F24\n24D98048497F24\n24D98048558F24\n24D98048605F24\n24D98048710F24\n24D98048565F24\n24D98048586F24\n24D98048604F24\n24D98048561F24\n24D98048606F24\n24D98048589F24\n24D98048555F24\n24D98048564F24\n24D98048614F24\n24D98048599F24\n24D98048590F24\n24D98048591F24\n24D98048583F24\n24D98048601F24\n24D98048580F24\n24D98048573F24\n24D98048618F24\n24D98048577F24\n24D98048567F24\n24D98048501F24\n24D98048610F24\n24D98048607F24\n24D98048711F24\n24D98048557F24\n24D98048616F24\n24D98048585F24\n24D98048572F24\n24D98048608F24\n24D98048592F24\n24D98048593F24\n24D98048569F24\n24D98048619F24\n24D98048579F24\n24D98048602F24\n24D98048498F24\n24D98048496F24\n24D98048581F24\n24D98048587F24\n24D98048562F24\n24D98048596F24\n24D98048611F24\n24D98048568F24\n24D98048615F24\n24D98048584F24\n24D98048563F24\n24D98026922F24\n24D98026921F24\n24D98048625F24\n24D98026935F24\n24D98026838F24\n24D98026836F24\n24D98026834F24\n24D98026928F24\n24D98026868F24\n24D98026869F24\n24D98026933F24\n24D98048388F24\n24D98028430G24\n24D98062685G24\n24D98071182G24\n24D98071082G24\n24D98038091G24\n24D98071057G24\n24D98038146G24\n24D98038133G24\n24D98074601G24\n24D98074572G24\n24D98074570G24\n24D98074606G24\n24D98074541G24\n24D98024371H24\n24D98024818H24\n24D98024808H24\n24D98002300H24\n24D98002281H24\n24D98024650H24\n24D98019809H24\n24D98019376H24\n24D98040257G24\n24D98040243G24\n24D98040260G24\n24D98040262G24\n24D98040258G24\n24D98040256G24\n24D98040263G24\n24D98040261G24\n24D98001851H24\n24D98038364G24\n24D98071566G24\n24D98071559G24\n24D98071562G24\n24D98038340G24\n24D98038333G24\n24D98038334G24\n24D98038326G24\n24D98071497G24\n24D98071498G24\n24D98071502G24\n24D98019747H24\n24D98038331G24\n24D98038335G24\n24D98038330G24\n24D98071567G24\n24D98071568G24\n24D98038319G24\n24D98038318G24\n24D98038315G24\n24D98038311G24\n24D98038304G24\n24D98038338G24\n24D98038322G24\n24D98038306G24\n24D98038302G24\n24D98038309G24\n24D98038303G24\n24D98038308G24\n24D98071563G24\n24D98038352G24\n24D98038339G24\n24D98038321G24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93200H24\n24D98093192H24\n24D98040821H24\n24D98093143G24\n24D98093198H24\n24D98093193H24\n24D98093343H24\n24D98093196H24\n24D98093210H24\n24D98093207H24\n24D98093202H24\n24D98093346H24\n24D98093197H24\n24D98093158G24\n24D98093146G24\n24D98093144G24\n24D98093199H24\n24D98093345H24\n24D98093201H24\n24D98093190H24\n24D98093195H24\n24D98093191H24\n24D98093187G24\n24D98093209H24\n24D98093161G24\n24D98093174G24\n24D98040823H24\n24D98093156G24\n24D98093189G24\n24D98039964B24\n24D98026855F24\n24D98039958B24\n24D98052243G24\n24D98020465H24\n24D98093992H24\n24D98026895F24\n24D98026879F24\n24D98029982A24\n24D98048955G24\n24D98026897F24\n24D98068161E24\n24D98053692E24\n24D98053766E24\n24D98050976E24\n\nProduct - 350P US Device, US English (American Airlines) - 2 Min CPR\nItem code: 350-STR-AA-AV\nUDI-DI code: 0506016712207\nSerial Numbers:\n24D98067253D24\n24D98067252D24\n24D98067251D24\n24D98067249D24\n24D98056938D24\n24D98067250D24\n24D98067248D24\n24D98067153D24\n24D98067160D24\n24D98067155D24\n24D98067163D24\n24D98067180D24\n24D98067182D24\n24D98067219D24\n24D98067186D24\n24D98067220D24\n24D98067221D24\n24D98067215D24\n24D98067156D24\n24D98067200D24\n24D98067195D24\n24D98067242D24\n24D98067231D24\n24D98067234D24\n24D98067244D24\n24D98067197D24\n24D98067232D24\n24D98067194D24\n24D98067166D24\n24D98067165D24\n24D98067161D24\n24D98067169D24\n24D98067241D24\n24D98067162D24\n24D98067192D24\n24D98067159D24\n24D98067198D24\n24D98067157D24\n24D98067203D24\n24D98067191D24\n24D98067158D24\n24D98067246D24\n24D98067225D24\n24D98067247D24\n24D98067206D24\n24D98067173D24\n24D98067204D24\n24D98067213D24\n24D98067209D24\n24D98067187D24\n24D98067207D24\n24D98067178D24\n24D98067217D24\n24D98067214D24\n24D98067222D24\n24D98067189D24\n24D98067212D24\n24D98067171D24\n24D98067170D24\n24D98067177D24\n24D98067223D24\n24D98067237D24\n24D98067172D24\n24D98067245D24\n24D98067210D24\n24D98067211D24\n24D98067205D24\n24D98067233D24\n24D98067208D24\n24D98067174D24\n24D98067226D24\n24D98067190D24\n24D98067164D24\n24D98067168D24\n24D98067167D24\n24D98067175D24\n24D98067176D24\n24D98067181D24\n24D98067185D24\n24D98067184D24\n24D98067216D24\n24D98067188D24\n24D98067183D24\n24D98067218D24\n24D98067179D24\n24D98067228D24\n24D98067229D24\n24D98067202D24\n24D98067236D24\n24D98067235D24\n24D98067201D24\n24D98067239D24\n24D98067230D24\n24D98067243D24\n24D98067196D24\n24D98067193D24\n24D98067240D24\n24D98067227D24\n24D98067224D24\n24D98067144D24\n24D98067238D24\n24D98067121D24\n24D98067131D24\n\nProduct - 350P US Device, US English with Gateway - 2 Min CPR\nItem code: 350-STR-US-GW\nUDI-DI code: 0506016712804\nSerial Numbers:\n24D98073174E24\n24D98033695E24\n24D98033694E24\n24D98033696E24\n24D98033711E24\n24D98033688E24\n24D98033686E24\n\nProduct - 360P US Device, US English - 2 Min CPR\nItem code: 360-STR-US-10\nUDI-DI code: 0506016712068\nSerial 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- SAM 450P   US Device, US English (2 min CPR)\nItem code: 450-STR-US-10\nUDI-DI code: 0506016712069\nSerial Numbers:\n24G90001624D24\n24G90001620D24\n24G90001610D24\n23G90004172G23\n23G90108237L23\n23G90108235L23\n23G90108212L23\n23G90108209L23\n23G90108236L23\n23G90108213L23\n23G90108208L23\n23G90108215L23\n23G90108210L23\n23G90108211L23\n23G90108495L23\n23G90108226L23\n23G90108322L23\n23G90108326L23\n23G90108222L23\n23G90108499L23\n23G90108225L23\n23G90108497L23\n23G90108498L23\n23G90108223L23\n23G90108492L23\n23G90108501L23\n23G90108240L23\n23G90108227L23\n23G90108242L23\n23G90108239L23\n23G90108684L23\n23G90108221L23\n23G90108247L23\n23G90108479L23\n23G90108241L23\n23G90108244L23\n23G90108246L23\n23G90108218L23\n23G90108313L23\n23G90108219L23\n23G90108477L23\n23G90108238L23\n23G90108473L23\n23G90108341L23\n23G90108368L23\n23G90108345L23\n23G90108502L23\n23G90108339L23\n23G90108365L23\n23G90108363L23\n23G90108347L23\n23G90108344L23\n23G90108342L23\n23G90108527L23\n23G90108524L23\n23G90108528L23\n23G90108525L23\n23G90108513L23\n23G90108506L23\n23G90108537L23\n23G90108531L23\n23G90108536L23\n23G90108532L23\n23G90108538L23\n23G90108526L23\n23G90108507L23\n23G90108523L23\n23G90108517L23\n23G90108515L23\n23G90108533L23\n23G90108205L23\n23G90108402L23\n23G90108203L23\n23G90108398L23\n23G90108408L23\n23G90108199L23\n23G90108417L23\n23G90108415L23\n23G90108409L23\n23G90108441L23\n23G90108692L23\n23G90108437L23\n23G90108207L23\n23G90108411L23\n23G90108399L23\n23G90108412L23\n23G90108401L23\n23G90108403L23\n23G90108416L23\n23G90108699L23\n23G90108440L23\n23G90108200L23\n23G90108198L23\n23G90108404L23\n23G90108201L23\n23G90108204L23\n23G90108655L23\n23G90108693L23\n23G90108202L23\n23G90108428L23\n23G90108419L23\n23G90108442L23\n23G90108410L23\n23G90108418L23\n23G90108405L23\n23G90108706L23\n23G90108707L23\n23G90108505L23\n23G90108709L23\n23G90108704L23\n23G90108708L23\n23G90108705L23\n23G90008119L23\n23G90108259L23\n23G90108256L23\n23G90108457L23\n23G90107062J23\n23G90108274L23\n23G90108271L23\n23G90009047L23\n23G90107662J23\n24G90013199H24\n24G90013402H24\n24G90013387H24\n24G90013395H24\n24G90013388H24\n24G90010488H24\n24G90013392H24\n24G90013397H24\n24G90013386H24\n24G90013390H24\n24G90013403H24\n24G90013391H24\n24G90013401H24\n24G90013389H24\n24G90013195H24\n24G90013396H24\n24G90013399H24\n24G90013404H24\n24G90013400H24\n24G90013652H24\n24G90013201H24\n24G90013635H24\n24G90013622H24\n24G90013617H24\n24G90013650H24\n24G90013628H24\n24G90013620H24\n24G90013192H24\n24G90013193H24\n24G90013627H24\n24G90013630H24\n24G90013224H24\n24G90013223H24\n24G90013632H24\n24G90013625H24\n24G90013636H24\n24G90013221H24\n24G90013197H24\n24G90013629H24\n24G90013631H24\n24G90013637H24\n24G90013633H24\n24G90013634H24\n24G90013623H24\n24G90013626H24\n24G90013385H24\n24G90013383H24\n24G90013382H24\n24G90013381H24\n24G90013378H24\n24G90013384H24\n24G90013612H24\n24G90013661H24\n24G90013648H24\n24G90013655H24\n24G90013656H24\n24G90013665H24\n24G90007696D24\n24G90007698D24\n24G90007706D24\n24G90007704D24\n24G90007701D24\n24G90008495D24\n24G90008493D24\n24G90008494D24\n24G90008496D24\n24G90008491D24\n24G90017726C24\n24G90008499D24\n24G90007690C24\n24G90012744D24\n24G90009451D24\n24G90012735D24\n24G90009476D24\n24G90009446D24\n24G90009455D24\n24G90009462D24\n24G90009449D24\n24G90009463D24\n24G90009480D24\n24G90009461D24\n24G90009544D24\n24G90009583D24\n24G90009441D24\n24G90009456D24\n24G90009443D24\n24G90009580D24\n24G90009447D24\n24G90009383D24\n24G90009457D24\n24G90009458D24\n24G90009445D24\n24G90009577D24\n24G90009584D24\n24G90009431D24\n24G90009468D24\n24G90009430D24\n24G90009433D24\n24G90009434D24\n24G90009432D24\n24G90009438D24\n24G90009437D24\n24G90009473D24\n24G90009435D24\n24G90009465D24\n24G90009467D24\n24G90009484D24\n24G90009439D24\n24G90009440D24\n24G90009448D24\n24G90009481D24\n24G90009474D24\n24G90009459D24\n24G90009472D24\n24G90009573D24\n24G90009426D24\n24G90009471D24\n24G90009453D24\n24G90009454D24\n24G90009477D24\n24G90009450D24\n24G90009478D24\n24G90009387D24\n24G90009452D24\n24G90008310D24\n24G90008303D24\n24G90008307D24\n24G90008306D24\n24G90008313D24\n24G90008314D24\n24G90008304D24\n24G90008301D24\n24G90008302D24\n24G90008276D24\n24G90008316D24\n24G90008318D24\n24G90008251D24\n24G90008337D24\n24G90008311D24\n24G90012963H24\n24G90001550D24\n24G90001553D24\n24G90001558D24\n24G90001605D24\n24G90001614D24\n24G90001611D24\n24G90001617D24\n24G90013288H24\n24G90013250H24\n24G90013294H24\n24G90013287H24\n24G90012927H24\n24G90013218H24\n24G90012916H24\n24G90012899H24\n24G90012936H24\n24G90012935H24\n24G90012929H24\n24G90012890H24\n24G90012934H24\n24G90012872H24\n24G90012925H24\n24G90013209H24\n24G90012895H24\n24G90012915H24\n24G90012930H24\n24G90012914H24\n24G90013370H24\n24G90013325H24\n24G90013366H24\n24G90013216H24\n24G90013369H24\n24G90013364H24\n24G90013365H24\n24G90013329H24\n24G90012922H24\n24G90013311H24\n24G90013324H24\n24G90012886H24\n24G90013320H24\n24G90013371H24\n24G90013215H24\n24G90013234H24\n24G90013292H24\n24G90013290H24\n24G90013296H24\n24G90013289H24\n24G90013291H24\n24G90013256H24\n24G90013253H24\n24G90013270H24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      "firm_fei_number": "3004123209",
      "recalling_firm": "HeartSine Technologies Ltd",
      "address_1": "207 Airport Road West",
      "city": "Belfast",
      "country": "United Kingdom",
      "additional_info_contact": "Joyce Staggs\n425-867-5497",
      "reason_for_recall": "Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.",
      "root_cause_description": "Process control",
      "action": "On 07/28/2026, Stryker sent several versions of an Urgent: Medical device recall letter that outlines two issues:  \n1) An issue with the membrane tail, an internal component, could cause an intermittent fault.  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.   \n2) A limited number of HeartSine samaritan PAD devices were distributed without the required maintenance insert.  This insert contains periodic maintenance instructions implemented as an additional risk control measure.  While most devices contain the maintenance insert, this voluntary correction is being initiated to ensure all end users have access to the supplemental maintenance information.  \n\n For the missing required maintenance insert (issue 2), Customers are instructed to:\n1. Identify impacted devices by verifying if your device serial numbers are included in the list at the link https://heartsinerecall.com/HeartSineSamaritanPAD/LookUp.  For this field action notice, select AED + Pad-Pak.  \n2. Download a copy of the missing maintenance insert when acknowledging the recall and store with your devices user manual until a replacement is received. \n\nFor questions or concerns, contact Stryker Customer Service at +1 8007879537, option 2, from 8 AM to 7 PM Eastern Time, Monday to Friday, your Authorized Distributor, or HeartSine Technologies Technical Support at heartsinesupport@stryker.com.",
      "product_quantity": "31,834",
      "distribution_pattern": "U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.",
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