{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "203909", "product_res_number": "Z-0302-2024", "event_date_initiated": "2023-09-29", "event_date_posted": "2023-11-14", "recall_status": "Open, Classified", "res_event_number": "93233", "product_code": "MKJ", "pma_numbers": [ "P160026" ], "product_description": "LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021", "code_info": "UDI: 00883873871706/ Serial number: 46687975", "firm_fei_number": "3015876", "recalling_firm": "Physio-Control, Inc.", "address_1": "11811 Willows Rd Ne", "city": "Redmond", "state": "WA", "postal_code": "98052-2003", "additional_info_contact": "Joyce Staggs\n425-867-4597", "reason_for_recall": "Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.", "root_cause_description": "Under Investigation by firm", "action": "On October 6, 2023, Stryker issued a \"Urgent Medical Device Correction\" Notification to affected consignees. Stryker ask consignees to take the following actions:\n\n1. Please check your internal inventory to locate the affected product listed on the attached business reply form.\n\n2. To confirm receipt of this Medical Device Notice and understanding of the provided information, please email the enclosed Business Reply Form (BRF) by October 31, 2023, to RSRecall@Stryker.com.\n\n3. Once the BRF is received, a Stryker Representative will contact you to arrange for corrective action on the device.\nThere are no additional actions that users can and should take.\n\n5. In the interim, Stryker recommends that you continue to use your LP15 v4 device.\n\n6. Maintain awareness of this communication internally until all required actions have been completed within your facility.\n\n7. Inform Stryker if any of the subject devices have been distributed to other organizations by contacting Stryker at:\na. Device Tracking: rsdevicetracking@stryker.com\nb. Website: https://www.strykeremergencycare.com/service-support-overview/device-registration/", "product_quantity": "1 units", "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.", "openfda": { "k_number": [ "K970741", "K883344", "K142803", "K954504", "K955923", "K141231", "K072923", "K981737", "K032051", "K982710", "K860676", "K111693", "K003565", "K981802", "K972241", "K122839", "K110825", "K992543", "K142915", "K150198", "K014157", "K091265", "K062233", "K042007", "K091561", "K012197", "K081371", "K012766", "K110168", "K954609", "K990106", "K020203", "K002079", "K001725", "K002445", "K971148", "K072430", "K080232", "K031187", "K081828", "K051475", "K110742", "K010634", "K980857", "K052465", "K970391", "K142430", "K964991", "K983393", "K123881", "K130454", "K040637", "K010257", "K020984", "K993072", "K022732", "K033474", "K131494", "K002232", "K984286", "K143714", "K992977", "K040056", "K002806", "K073089", "K942850", "K072596", "K990762", "K011901", "K033144", "K120350", "K984582", "K082937", "K943698", "K070455", "K013896", "K052161", "K040404", "K102972", "K110526", "K940445", "K002280", "K041459", "K110361", "K063375", "K133659", "K870622", "K040438", "K052057", "K141774", "K112432", "K014209", "K962359", "K063510", "K103186", "K883341", "K955828", "K932931", "K051632", "K882067", "K122600", "K141795", "K973486", "K050004", "K040479", "K020288", "K060559", "K926172", "K965117", "K970719", "K042417", "K960329", "K052316", "K020715", "K062537", "K041883", "K983287", "K110978", "K133269", "K982025", "K073716", "K103567", "K982992", "K000638", "K021168", "K892065", "K972418", "K953204", "K955628", "K062970", "K080903", "K120406", "K991910", "K991007", "K030898", "K033771", "K993745", "K883584", "K131525", "K003548", "K092391", "K993533", "K991556", "K991871", "K071025", "K020743", "K853564", "K072812", "K150055", "K100565", "K112761", "K003228", "K012428", "K023854", "K011541", "K892005", "K941262", "K040775", "K091548", "K954957", "K952101", "K130153", "K013425", "K955882", "K942344", "K130684", "K041067", "K032439", "K051134", "K972970", "K033896", "K934692", "K932028", "K955890", "K061707", "K012030", "K031987", "K941970", "K971149", "K051076", "K121853", "K010214", "K993036", "K040256", "K032421", "K935922", "K091943", "K072233", "K082861", "K063119", "K120907", "K082090", "K113787", "K131550", "K010207", "K955854", "K060934", "K011144", "K041892", "K062177", "K982264", "K090989", "K081081", "K021453", "K022210", "K111594", "K042404", "K120536", "K925936", "K010918", "K033275", "K133484", "K142709", "K102496", "K983307", "K133239", "K092598", "K122758", "K081259", "K042088", "K133441", "K896919", "K011388", "K003819", "K033642", "K022929", "K080421", "K110154" ], "pma_number": [ "P160032", "P190013", "P160034", "P160008", "P190007", "P180028", "P200007", "P160012", "P170018", "P210015", "P200005", "P160022", "P160033", "P200004", "P160028", "P160015", "P160026" ], "registration_number": [ "", "1423537", "9681191", "3030733800", "3002807314", "3004035727", "3012494290", "3002714378", "3029871637", "3026007685", "3009077524", "3012502601", "3014579161", "3043226252", "3013517171", "1218058", "3003521780", "1921846", "3012972516", "3038259592", "3013826848", "3003537036", "3005621729", "3014572985", "1223925", "3006108746", "2112020", "1423662", "3008717264", "8020045", "3030446844", "3026976873", "3010317211", "3021559257", "9681860", "3004906872", "3010783192", "3020460367", "3010839093", "3030677", "3013596024", "3012104670", "3005906887", "3027815", "3015876", "3013557562", "3003800159", "3017422354", "3009886119", "3010030355", "3003867964", "1219103", "1317188", "1320894", "1720929", "1220908", "3013500228", "1930027", "3011823740", "3000126629", "3015997711", "2132111", "3012607778", "3010703925", "3004123209", "3015134086", "3007029079" ], "fei_number": [ "", "3030733800", "3002807314", "3004035727", "3012494290", "3002714378", "3029871637", "3026007685", "3009077524", "3012502601", "1000524572", "3001451571", "3014579161", "1000305720", "3043226252", "3013517171", "1218058", "3001236905", "3003521780", "1000148701", "1921846", "3012972516", "3038259592", "3013826848", "3003537036", "3005621729", "3014572985", "3006108746", "2112020", "3008717264", "3008207730", "3030446844", "3026976873", "3010317211", "3021559257", "1000127185", "3004906872", "6736", "3010783192", "3020460367", "3010839093", "3000215273", "3012104670", "3013596024", "3005906887", "1000140026", "3015876", "3013557562", "3003800159", "3017422354", "3009886119", "3010030355", "3003867964", "1317188", "1720929", "1220908", "3013500228", "1930027", "3011823740", "3000126629", "3003491392", "3015997711", "3012607778", "3010703925", "3004123209", "3015134086", "3007029079" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }