{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198704", "product_res_number": "Z-1256-2023", "event_date_initiated": "2023-02-01", "event_date_posted": "2023-03-15", "recall_status": "Open, Classified", "res_event_number": "91716", "product_code": "FPO", "product_description": "Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location.\nModel: 650705550001", "code_info": "GTIN: 07613327559118\nSerial Numbers: 2208002066, 2208002071, 2209001508, 2208001664", "firm_fei_number": "1831750", "recalling_firm": "Stryker Medical Division of Stryker Corporation", "address_1": "3800 E Centre Ave", "city": "Portage", "state": "MI", "postal_code": "49002-5826", "additional_info_contact": "SAME\n269-389-8306", "reason_for_recall": "Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport.", "root_cause_description": "Under Investigation by firm", "action": "Stryker issued Urgent Medical Device Correction letter dated 2/1/23. Letter states reason for recall, health risk and action to take: \n\n1.\tLocate the units listed on the attached business reply form and remove them from service until repairs are complete.\n2.\tReturn the enclosed business reply form to confirm receipt of this notification by fax +1 269 488 8691 or email productfieldaction@stryker.com. \n3.\tStryker will contact you to arrange for the modification/repair of your Power-PRO 2.\n4.\tIf you have loaned or sold or disposed of any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form.\nQuestions or concerns, contact Customer Service at +1 800 327 0770 Monday through Friday from 8:00 a.m. to 6:00 p.m. ET.", "product_quantity": "4 units", "distribution_pattern": "US Nationwide distribution in the states of NY, VA.", "openfda": { "k_number": [ "K072598", "K942948", "K840124", "K943529", "K933071", "K922808", "K853421", "K844578", "K961437", "K943262", "K923730", "K945431", "K871556", "K932260", "K943864", "K955766", "K761147", "K792570", "K861410", "K920704", "K935297", "K843439", "K933366", "K933060", "K854304", "K863083", "K902503", "K840122", "K914543", "K952447", "K864269", "K962181", "K874332", "K943969", "K946101", "K840125", "K862959", "K881845", "K900872", "K113598", "K862441", "K895740", "K943528", "K840920", "K801935", "K873181", "K972528", "K922809", "K884759", "K904011" ], "registration_number": [ "3008058231", "1033902", "3001947547", "2183191", "3031582440", "3006750986", "3030927791", "9615386", "3007836437", "3004499949", "3008975187", "1528440", "1000122786", "3008434522", "2184033", "3007912863", "3021559257", "3008386649", "3009238346", "3020460367", "3042991836", "3007662999", "3003749961", "3017884063", "9681454", "3014270896", "3007583774", "2183887", "3027847726", "3006554931", "3006123327", "8022752", "3017421556", "2024242", "1043549", "1824206", "3002668219", "3007515312", "3006513362", "3005206084", "3011910987", "3011574775", "3009567010", "3009222501", "3033849261", "2020676", "3017181414", "3015223105", "3030488262", "3002818647", "3038197284", "3012330365", "3038141559", "3005070829", "3020978037", "3007420694", "3043654660", "3011659880", "3006554924", "3006697241", "1000211739", "3011719874", "8030903", "2428983", "3031563141", "3017708892", "3026311463", "3007802293", "3011537487", "3003770834", "8022103", "1831750", "9613910", "3005878604", "8010652", "3006975482", "3027332478", "3017844600", "3007123908", "3045752744", "3013964848", "3007744192", "2518443", "3010509576", "1721113", "3003674698", "3010373263", "3009171220", "3006157842", "3006891315", "3042262500", "2027797", "3014739961", "3013856565", "3016678414", "3045978136", "1422399", "3014101053", "3008042739", "3037012186", "3004198457", "1523574", "3006897996", "3009688852", "1931947", "3010703925", "3006342679", "3013408788", "3008881803", "3005706637" ], "fei_number": [ "3008058231", "1033902", "3001947547", "3002913923", "2183191", "3031582440", "3006750986", "1000143830", "3030927791", "3007836437", "3004499949", "3008975187", "1000122786", "3008434522", "1000122527", "1841", "3007912863", "3021559257", "3008386649", "3009238346", "3020460367", "3042991836", "3007662999", "3003749961", "3002808508", "3017884063", "3014270896", "3007583774", "2183887", "3027847726", "3006554931", "3006123327", "3017421556", "2024242", "1043549", "1000125727", "1824206", "3002668219", "3007515312", "3006513362", "3002572935", "3005206084", "3011910987", "3011574775", "3009567010", "3009222501", "3033849261", "2020676", "3017181414", "3015223105", "3030488262", "1000115792", "3002818647", "3038197284", "3012330365", "3038141559", "3005070829", "3020978037", "3007420694", "1000118429", "3043654660", "3011659880", "3006554924", "3006697241", "1000211739", "3011719874", "3031563141", "3017708892", "3026311463", "3007802293", "3011537487", "3003770834", "1831750", "3005878604", "3006975482", "3027332478", "3017844600", "3007123908", "3045752744", "3013964848", "3007744192", "2518443", "3010509576", "1721113", "3003674698", "3010373263", "3009171220", "3006157842", "3006891315", "3042262500", "3004574120", "3014739961", "3013856565", "3016678414", "3045978136", "3014101053", "3008042739", "2427360", "3037012186", "3004198457", "1523574", "3006897996", "3003769112", "3009688852", "3010703925", "3006342679", "3000134760", "3013408788", "3008881803", "3005706637" ], "device_name": "Stretcher, Wheeled", "medical_specialty_description": "General Hospital", "regulation_number": "880.6910", "device_class": "2" } } ] }