{ "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": "218656", "product_res_number": "Z-2065-2026", "event_date_initiated": "2026-04-13", "event_date_posted": "2026-05-04", "recall_status": "Open, Classified", "res_event_number": "98418", "product_code": "MKJ", "pma_numbers": [ "P160026" ], "product_description": "LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045;\n\nLIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096;\n\nLIFEPAK 35, REF: 99335-000013, 99335-000031;\n\nLIFEPAK 20e, REF: 99507-000122", 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20e/0088387385386320082448935344, 0088387385386320082448935408, 0088387385386321080249537075/\n48935344, 48935408, 49537075", "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\n425-867-5497", "reason_for_recall": "Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.", "root_cause_description": "Process control", "action": "On 04/13/2026, recall notices were sent to customers who were asked to do the following:\n1) Return the business reply form by email to RSRecall@Stryker.com to confirm receipt of this notification.\n2) Upon receipt of the completed business reply form, firm will contact you to arrange for corrective action on the device if service has not been performed.\n3) Continue to follow the Operating Instructions and perform the daily checks and user tests. These tests can be found in the chapter \"Maintaining the Equipment\" subsection \"General Maintenance and Testing\".\n4) Maintain awareness of this communication internally until all required actions have been completed within your facility. Please ensure this letter is kept with the affected device until the correction has been completed.\n5) Inform firm if any of the subject devices have been distributed to other organizations. If so, provide contact details, so the firm can inform the recipients.\n\nIf you have any questions or concerns, please contact the firm's Customer Service +1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday - Friday or by email at medtechsup@stryker.com", "product_quantity": "206", "distribution_pattern": "US Nationwide distribution in the states of MI, WA, KY, IN, FL, NC, TX, LA, VA, NY, MA, CO, PA, OH, SC, OK, MN, WV, NJ, WI.", "openfda": { "k_number": [ "K112432", "K002445", "K133484", "K081371", "K092598", "K081828", "K052161", "K003565", "K040256", "K002232", "K970391", "K091548", "K080421", "K042088", "K022732", "K141774", "K042417", "K013425", "K120907", "K003228", "K033474", "K082090", "K062970", "K993533", "K033771", "K060934", "K990106", "K014157", "K981802", "K051632", "K020743", "K972241", "K002280", "K002806", "K063375", "K991007", "K082937", "K130684", "K110361", "K011144", "K062537", "K954957", "K883344", "K122758", "K110526", "K031987", "K130153", 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"pma_number": [ "P160032", "P160026", "P160033", "P160022", "P200004", "P170018", "P200005", "P160008", "P180028", "P190013", "P190007", "P160034", "P210015", "P200007", "P160015", "P160012", "P160028" ], "registration_number": [ "1223925", "1219103", "1930027", "3012502601", "3015134086", "", "3003800159", "9681191", "2112020", "3013557562", "3002714378", "3004906872", "3004123209", "3009886119", "3013500228", "3005621729", "3030677", "1423537", "1320894", "3013517171", "3015997711", "3010783192", "3004035727", "3008717264", "3012104670", "3005906887", "3012494290", "3000126629", "3030446844", "3012607778", "3010317211", "3010839093", "3003521780", "3020460367", "3006108746", "3010703925", "3043226252", "3012972516", "1423662", "3021559257", "8020045", "3002807314", "3030733800", "1720929", "3015876", "3009077524", "3010030355", "1220908", "3038259592", "3003867964", "3027815", "2132111", "1317188", "3003537036", "3026976873", "1218058", "3014579161", "9681860", "3026007685", "3007029079", "3011823740", "3017422354", "3029871637", "1921846", "3013596024", "3021632375", "3013826848", "3014572985" ], "fei_number": [ "", "1930027", "3012502601", "3015134086", "3003800159", "2112020", "3013557562", "3002714378", "3004906872", "3004123209", "3009886119", "3013500228", "1000127185", "3013517171", "3015997711", "3005621729", "3010783192", "3004035727", "3008717264", "3012104670", "3005906887", "3008207730", "3012494290", "1000305720", "1000148701", "3000126629", "3030446844", "3012607778", "3010317211", "3010839093", "3003521780", "3020460367", "3006108746", "3010703925", "3000215273", "3043226252", "3012972516", "3021559257", "3002807314", "3030733800", "1720929", "3015876", "1000524572", "3003491392", "1000140026", "3009077524", "3010030355", "1220908", "3038259592", "3003867964", "3001451571", "1317188", "6736", "3003537036", "3026976873", "1218058", "3014579161", "3001236905", "3026007685", "3007029079", "3011823740", "3017422354", "3029871637", "1921846", "3013596024", "3021632375", "3013826848", "3014572985" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }