{ "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": "210079", "product_res_number": "Z-0230-2025", "event_date_initiated": "2024-08-30", "event_date_posted": "2024-10-25", "recall_status": "Open, Classified", "res_event_number": "95373", "product_code": "MKJ", "pma_numbers": [ "P160026" ], "product_description": "LIFEPAK 15 (LP15) Model/Catalog Numbers:\no 97577-000101\no 99577-000046\no 99577-000055\no 99577-000061\no 99577-000076\no 99577-001250\no 99577-001255\no 99577-001256\no 99577-001368\no 99577-001955\no 99577-001956\no 99577-001957\no 99577-001958\no 99577-001962\nLIFEPAK 15 intended use monitor/defibrillator.", "code_info": "LIFEPAK 15 (LP15) Model/Catalog Numbers:\no 97577-000101\no 99577-000046\no 99577-000055\no 99577-000061\no 99577-000076\no 99577-001250\no 99577-001255\no 99577-001256\no 99577-001368\no 99577-001955\no 99577-001956\no 99577-001957\no 99577-001958\no 99577-001962\n\nUDI-DI codes:\no 00883873808214\no 00883873988022\no 00883873979426\no 00883873979358\no 00883873911693\no 00883873979198\no 00883873911648\no 00883873884386\no 00883873871713\no 00883873871706\no 00883873871690\no 00883873871683\no 00883873911631\no 00883873871645\n\nSerial Numbers:\no 45435833\no 46470647\no 46686048\no 46686573\no 46686708\no 46687360\no 46906073\no 49037777\no 49704552\no 38166647\no 38282988\no 38290136\no 38291331\no 38802782\no 39541663\no 39541666\no 39752193\no 40259639\no 41446867\no 41447020\no 41453331\no 42325059\no 43574409\no 43984215\no 45040678\no 45308104\no 45455023\no 46017745\no 46572054\no 46576300\no 48349664\no 48605645\no 48605663\no 49001744\no 49025185\no 49070762\no 49087040\no 49087053\no 49224619\no 49374174\no 49422314\no 49619921\no 38200440\no 38805564\no 38805583\no 39382735\no 41446693\no 41446882\no 41446975\no 41446977\no 41447027\no 41453239\no 41893891\no 42324176\no 42610924\no 43181935\no 43182268\no 43182389\no 43462227\no 43465372\no 43487806\no 43610792\no 43791346\no 43841374\no 43860850\no 43862247\no 43869747\no 44169862\no 44356379\no 44360003\no 44601246\no 45590467\no 45907317\no 46364496\no 46691551\no 47447195\no 47515791\no 47539203\no 47539310\no 47785570\no 47794250\no 48524850\no 48583111\no 48585709\no 48600317\no 48605407\no 48605467\no 48704914\no 48749443\no 49022830\no 49031342\no 49036187\no 49056308\no 49057928\no 49123367\no 49126651\no 49127012\no 49132399\no 49132740\no 49134638\no 49511402\no 49513814", "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": "Due to an out of tolerance tool being used on monitor/defibrillator systems.", "root_cause_description": "Vendor change control", "action": "On 09/30/2024, the firm mailed an \"URGENT: MEDICAL DEVICE CORRECTION\" Letter to customers informing them that Stryker discovered that an out of tolerance service tool was used on affected LP15 devices in which there is a potential for Noninvasive Blood Pressure (NIBP), System or Auxiliary Power Connectors to be loose. There is a possibility that water or dust may accumulate in the ingress and can lead to permanent or intermittent failures.\n\nCustomers are instructed to:\n1. Immediately check internal inventory to locate the product listed on the attached business reply form.\n2. To confirm receipt of this Medical Device Correction Notice and understanding of the provided information, email the enclosed Business Reply Form (BRF) by October 31st, 2024 date, to RSRecall@Stryker.com.\n3. Upon receipt of the completed business reply form, Stryker will contact customers to arrange for corrective action on the device.\n4. There are no additional actions that users can and should take. Please 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 .\n5. In the interim, Stryker recommends that you continue to use your LP15 device.\n6. 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.\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/\nIf you have any questions or concerns, please contact Customer Service +1 800 442 1142 or by email RSRecall@Stryker.com.", "product_quantity": "105 systems", "distribution_pattern": "U.S.: CT, GA, MA, NY, OH, WA, and WV.\n\nO.U.S.: N/A", "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", 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"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" } } ] }