{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221890",
      "product_res_number": "Z-3120-2026",
      "event_date_initiated": "2026-07-27",
      "event_date_posted": "2026-09-04",
      "recall_status": "Open, Classified",
      "res_event_number": "99568",
      "product_code": "MKJ",
      "pma_numbers": [
        "P160008"
      ],
      "product_description": "HeartSine SAM 350P\r\n350P US Device, US English - 2 Min CPR\r\nUDI-DI codes:\r\n0506016712067\r\n\r\n350P US Device, US English (American Airlines) - 2 Min CPR\r\nUDI-DI code:\r\n0506016712207\r\n\r\n350P US Device, US English with Gateway - 2 Min CPR\r\nUDI-DI code:\r\n0506016712804\r\n\r\nHeartSine SAM 360P\r\n360P US Device, US English - 2 Min CPR\r\nUDI-DI code:\r\n0506016712068\r\n\r\nHeartSine SAM 450P\r\nSAM 450P   US Device, US English (2 min CPR)\r\nUDI-DI code:\r\n0506016712069\r\n\r\nThe HeartSine samaritan PAD (Public Access Defibrillator) Models SAM 350P, SAM 360P and SAM 450P are indicated for use on victims of cardiac arrest who are exhibiting the following signs:\r\n\" Unconscious\r\n\" Not breathing\r\n\" Without circulation (without a pulse)\r\nThe devices are indicated for use on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak (Pad-Pak-01 or Pad-Pak-07). They are indicated for use on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the Pediatric-Pad (Pad-Pak-02).",
      "code_info": "350P US Device, US English - 2 Min CPR\nItem code: 350-STR-US-10\nUDI-DI codes: 0506016712067\nSerial 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US Device, US English (American Airlines) - 2 Min CPR\nItem code: 350-STR-AA-AV\nUDI-DI code: 0506016712207\nSerial Numbers:\n23D98109359I23\n23D98109384I23\n23D98110320I23\n23D98110321I23\n23D98119022J23\n23D98119023J23\n23D98119024J23\n23D98119025J23\n23D98119026J23\n23D98119027J23\n23D98119028J23\n23D98119029J23\n23D98119030J23\n23D98119031J23\n23D98119032J23\n23D98119033J23\n23D98119034J23\n23D98119035J23\n23D98119036J23\n23D98119037J23\n23D98119039J23\n23D98119040J23\n23D98119041J23\n23D98119042J23\n24D98041472B24\n24D98041569B24\n24D98041710B24\n24D98041712B24\n24D98041724B24\n24D98041726B24\n24D98041729B24\n24D98041734B24\n24D98041738B24\n24D98041746B24\n24D98041749B24\n24D98041755B24\n24D98041758B24\n24D98041759B24\n24D98041760B24\n24D98041765B24\n24D98041768B24\n24D98041774B24\n24D98041781B24\n24D98041785B24\n24D98041786B24\n24D98041801B24\n24D98041802B24\n24D98041804B24\n24D98067144D24\n24D98067171D24\n24D98067175D24\n24D98067179D24\n24D98067180D24\n24D98067181D24\n24D98067182D24\n24D98067177D24\n24D98067178D24\n24D98067183D24\n24D98067184D24\n24D98067185D24\n24D98067186D24\n24D98067187D24\n24D98067188D24\n24D98067189D24\n24D98067190D24\n24D98067191D24\n24D98067192D24\n24D98067193D24\n24D98067194D24\n24D98067195D24\n24D98067196D24\n24D98067197D24\n24D98067198D24\n24D98067200D24\n24D98067201D24\n24D98067202D24\n24D98067203D24\n24D98067204D24\n24D98067205D24\n24D98067206D24\n24D98067207D24\n24D98067208D24\n24D98067209D24\n24D98067210D24\n24D98067211D24\n24D98067212D24\n24D98067213D24\n24D98067214D24\n24D98067215D24\n24D98067216D24\n24D98067217D24\n24D98067218D24\n24D98067219D24\n24D98067220D24\n24D98067221D24\n24D98067222D24\n24D98067223D24\n24D98067224D24\n24D98067225D24\n24D98067226D24\n24D98067227D24\n24D98067228D24\n24D98067229D24\n24D98067230D24\n24D98067231D24\n24D98067232D24\n24D98067233D24\n24D98067234D24\n24D98067235D24\n24D98067236D24\n24D98067237D24\n24D98067238D24\n24D98067239D24\n24D98067240D24\n24D98067241D24\n24D98067242D24\n24D98067243D24\n24D98067244D24\n24D98067245D24\n24D98067246D24\n24D98067247D24\n24D98067248D24\n24D98067249D24\n24D98067250D24\n24D98067251D24\n24D98067252D24\n24D98067253D24\n24D98056938D24\n24D98067153D24\n24D98067155D24\n24D98067156D24\n24D98067157D24\n24D98067158D24\n24D98067159D24\n24D98067160D24\n24D98067161D24\n24D98067162D24\n24D98067163D24\n24D98067164D24\n24D98067165D24\n24D98067166D24\n24D98067167D24\n24D98067168D24\n24D98067169D24\n24D98067170D24\n24D98067172D24\n24D98067173D24\n24D98067174D24\n24D98067176D24\n24D98067121D24\n24D98067131D24\n\n350P US Device, US English with Gateway - 2 Min CPR\nItem code: 350-STR-US-GW\nUDI-DI code: 0506016712804\nSerial Numbers:\n24D98033695E24\n24D98033696E24\n24D98033711E24\n24D98073174E24\n24D98033694E24\n24D98033688E24\n\nHeartSine SAM 360P\n360P US Device, US English - 2 Min CPR\nItem code: 360-STR-US-10\nSerial 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SAM 450P\nSAM 450P   US Device, US English (2 min CPR)\nItem code: 450-STR-US-10\nUDI-DI code: 0506016712069\nSerial Numbers:\n22G91037109D22\n22G91037113D22\n22G91037115D22\n22G91037234D22\n22G91037235D22\n22G91037238D22\n22G91037239D22\n23G90000012H23\n23G90000015H23\n23G90000182H23\n23G90000188H23\n23G90000198H23\n23G90000201H23\n23G90000218K23\n23G90000252H23\n23G90000273H23\n23G90000300L23\n23G90000457J23\n23G90000458J23\n23G90000459J23\n23G90000460J23\n23G90000461J23\n23G90000462J23\n23G90000463J23\n23G90000465J23\n23G90000466J23\n23G90000467J23\n23G90000468J23\n23G90000469J23\n23G90000470J23\n23G90000471J23\n23G90000472J23\n23G90000474J23\n23G90000475J23\n23G90000476J23\n23G90000477J23\n23G90000479J23\n23G90000481J23\n23G90000482J23\n23G90000483J23\n23G90000485J23\n23G90000486J23\n23G90000487J23\n23G90000488J23\n23G90000489J23\n23G90000490J23\n23G90000491J23\n23G90000493J23\n23G90000494J23\n23G90000495J23\n23G90000496J23\n23G90000497J23\n23G90000498J23\n23G90000499J23\n23G90001076L23\n23G90001157L23\n23G90001296H23\n23G90001297H23\n23G90001298H23\n23G90001299H23\n23G90001300H23\n23G90001306H23\n23G90001307H23\n23G90001309H23\n23G90001310H23\n23G90001311H23\n23G90001312H23\n23G90001315H23\n23G90001316H23\n23G90001317H23\n23G90001319H23\n23G90001320H23\n23G90001321H23\n23G90001322H23\n23G90001323H23\n23G90001325H23\n23G90001326H23\n23G90001327H23\n23G90001328H23\n23G90001329L23\n23G90001330H23\n23G90001331H23\n23G90001332H23\n23G90001334H23\n23G90001336H23\n23G90001337H23\n23G90001413H23\n23G90001414H23\n23G90001425H23\n23G90001426H23\n23G90001427H23\n23G90001428H23\n23G90001430H23\n23G90001432H23\n23G90001433H23\n23G90001579L23\n23G90002485J23\n23G90002486J23\n23G90002487J23\n23G90002488J23\n23G90002489J23\n23G90002491J23\n23G90002492J23\n23G90002493J23\n23G90002494J23\n23G90002496J23\n23G90002497J23\n23G90002498J23\n23G90002499J23\n23G90002500J23\n23G90003117H23\n23G90003118A23\n23G90003626L23\n23G90003849J23\n23G90003850J23\n23G90003851J23\n23G90003852J23\n23G90003853J23\n23G90003854J23\n23G90003863J23\n23G90003864J23\n23G90003865J23\n23G90003866J23\n23G90003867J23\n23G90003868J23\n23G90003869J23\n23G90003870J23\n23G90003871J23\n23G90003895H23\n23G90003898H23\n23G90003900H23\n23G90003905H23\n23G90003914H23\n23G90003915L23\n23G90003916H23\n23G90003917H23\n23G90003919H23\n23G90003920H23\n23G90003921H23\n23G90003922H23\n23G90003923H23\n23G90003924H23\n23G90003925H23\n23G90003926H23\n23G90003929H23\n23G90003930H23\n23G90003931H23\n23G90003932H23\n23G90003933H23\n23G90003934H23\n23G90003935H23\n23G90003936H23\n23G90003937H23\n23G90003939H23\n23G90003940H23\n23G90003941H23\n23G90003943H23\n23G90003944H23\n23G90003946H23\n23G90003947H23\n23G90003948H23\n23G90003949H23\n23G90003950H23\n23G90003951H23\n23G90003953H23\n23G90003954H23\n23G90003955H23\n23G90003956L23\n23G90003957H23\n23G90003958H23\n23G90003959H23\n23G90003960H23\n23G90003961H23\n23G90003962H23\n23G90003963H23\n23G90003964H23\n23G90003965H23\n23G90003966H23\n23G90003967H23\n23G90003969H23\n23G90003970H23\n23G90004442L23\n23G90004637H23\n23G90004943I23\n23G90004994I23\n23G90004997I23\n23G90006350L23\n23G90006617L23\n23G90006671J23\n23G90006672J23\n23G90006673J23\n23G90006674J23\n23G90006675J23\n23G90006676J23\n23G90006677J23\n23G90006678J23\n23G90006679J23\n23G90006680J23\n23G90006682J23\n23G90006683J23\n23G90006684J23\n23G90006685J23\n23G90006686J23\n23G90006687J23\n23G90006688J23\n23G90006689J23\n23G90006690J23\n23G90006691J23\n23G90006694J23\n23G90006695J23\n23G90006697J23\n23G90006698J23\n23G90006699J23\n23G90006700J23\n23G90006701J23\n23G90007992J23\n23G90007993J23\n23G90007994J23\n23G90007995J23\n23G90007996J23\n23G90007997J23\n23G90007998J23\n23G90007999J23\n23G90008101L23\n23G90008663L23\n23G90008706L23\n23G90008751G23\n23G90009002L23\n23G90009006H23\n23G90009007L23\n23G90009008H23\n23G90009012H23\n23G90009017H23\n23G90009019H23\n23G90009024H23\n23G90009029H23\n23G90009067H23\n23G90009072H23\n23G90009074H23\n23G90009075H23\n23G90009076H23\n23G90009080H23\n23G90009085H23\n23G90009086H23\n23G90009093H23\n23G90009296H23\n23G90009305H23\n23G90009311H23\n23G90009330K23\n23G90009339K23\n23G90009564L23\n23G90009591L23\n23G90009605H23\n23G90009690H23\n23G90009692H23\n23G90009695H23\n23G90009696H23\n23G90009697H23\n23G90009707H23\n23G90009710H23\n23G90009718H23\n23G90009738H23\n23G90009739H23\n23G90009742H23\n23G90009778H23\n23G90009830K23\n23G90009993L23\n23G90009997L23\n23G90100110K23\n23G90100277L23\n23G90100312K23\n23G90100327K23\n23G90100389K23\n23G90100442K23\n23G90100801L23\n23G90100913L23\n23G90100915L23\n23G90100917L23\n23G90100918L23\n23G90100920L23\n23G90100921L23\n23G90100922L23\n23G90100923L23\n23G90100924L23\n23G90100926L23\n23G90100927L23\n23G90100929L23\n23G90100935L23\n23G90100936L23\n23G90100937L23\n23G90100942L23\n23G90100943L23\n23G90100944L23\n23G90100945L23\n23G90100947L23\n23G90100948L23\n23G90100949L23\n23G90100950L23\n23G90100953L23\n23G90100954L23\n23G90100955L23\n23G90100956L23\n23G90100957L23\n23G90100958L23\n23G90100959L23\n23G90100961L23\n23G90102084K23\n23G90102157K23\n23G90102159K23\n23G90102176K23\n23G90102245L23\n23G90102285K23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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\n425-867-4597",
      "reason_for_recall": "Due to a damaged (over stretched) membrane tail that causes an intermittent fault.",
      "root_cause_description": "Process control",
      "action": "On 07/28/2026, several versions of an \"Urgent: Medical device recall\" letter that outlines multiple issues:\n1) Stryker identified an issue with the membrane tail, an internal component, which 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) Stryker has also identified that 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.  This issue was identified through a customer complaint.\n\nFor the membrane tail issue (issue 1), Customers are instructed to:",
      "product_quantity": "11,912",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME MI, MN, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SD,TN, TX, UT, VA, WA, WI, WV and WY. The countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Hong Kong, Indonesia, ISRAEL, JAPAN, Malaysia, Netherlands, Philippines, POLAND, SINGAPORE, South Korea, Taiwan, Thailand and UNITED KINGDOM.",
      "openfda": {
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