{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 19 } }, "results": [ { "cfres_id": "188079", "product_res_number": "Z-2205-2021", "event_date_initiated": "2021-05-12", "event_date_created": "2021-08-06", "recall_status": "Open, Classified", "res_event_number": "88199", "product_code": "FPO", "product_description": "Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000", "code_info": "UDI (DI#): 07613327278187", "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": "Victoria Haney \n269-389-8306", "reason_for_recall": "Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the\ncorrect use environment, but home users may not be aware of or fully understand these instructions\nintended for healthcare professionals", "root_cause_description": "Under Investigation by firm", "action": "Stryker notified users/consumers via written notification Urgent Medical Device Removal letter notified via FedEx on Friday, June 18, 2021. In addition, customers may be contacted by phone or email. International distribution divisions were notified by validated electronic system (Trackwise) on May 13, 2021.\n\n Letter states reason for recall, health risk and action to take:\nCustomers are instructed to:\n1. Identify the medical device shipped to your location (see the attached business reply form for product details and serial number).\n2. If you are using the product in a home, Stryker recommends that you discontinue use of the product.\n3. Complete and sign the enclosed business reply form.\na. Return this signed letter by fax (269) 488-8691or email productfieldaction@stryker.com to Stryker's Regulatory Department.\n\n1.\tIdentify the medical device shipped to your location (see the attached business reply form for product details and serial number). \n2.\tIf you are using the product in a home, Stryker recommends that you discontinue use of the product.\n3.\tComplete and sign the enclosed business reply form. \na.\tReturn this signed letter by fax 269 488 8691 or email productfieldaction@stryker.com to Strykers Regulatory Department.\n4.\tUpon receipt of the signed business reply form, Stryker will contact you to arrange the removal of your product(s) if applicable.\n\nIf you have any questions or concerns, contact us at +1 269 389 8306 or productfieldaction@stryker.com. We apologize for any disruption this may cause.", "product_quantity": "3 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.", "openfda": { "k_number": [ "K862441", "K761147", "K843439", "K920704", "K922808", "K801935", "K874332", "K943262", "K935297", "K943528", "K792570", "K923730", "K873181", "K914543", "K840122", "K933060", "K933366", "K955766", "K946101", "K922809", "K862959", "K863083", "K904011", "K895740", "K881845", "K902503", "K840124", "K900872", "K933071", "K871556", "K932260", "K943529", "K840125", "K864269", "K840920", "K072598", "K972528", "K962181", "K943864", "K884759", "K861410", "K943969", "K961437", "K113598", "K952447", "K844578", "K854304", "K853421", "K942948", "K945431" ], "registration_number": [ "3020460367", "3003674698", "3007912863", "3013856565", "2024242", "3027332478", "2183191", "3007744192", "1043549", "3027847726", "3031582440", "3038197284", "3004198457", "3002818647", "3045978136", "3004499949", "3006554924", "1523574", "3042262500", "3007836437", "3001947547", "3006157842", "3006513362", "3010509576", "3008058231", "3006897996", "3002668219", "3006891315", "3026311463", "2184033", "3005206084", "3009567010", "3030488262", "3014270896", "9681454", "3017421556", "8030903", "8010652", "3031563141", "3043654660", "3015223105", "3020978037", "3017181414", "3007420694", "3006554931", "1422399", "2518443", "3016678414", "3017884063", "3021559257", "3012330365", "9615386", "3017708892", "1000122786", "3007802293", "3006123327", "3013408788", "3003770834", "3010373263", "3006342679", "3011574775", "3008042739", "3014739961", "3011719874", "3009222501", "1000211739", "1931947", "3045752744", "9613910", "3011910987", "3037012186", "1033902", "3030927791", "3010703925", "3005706637", "3005070829", "2027797", "3008386649", "3009688852", "3007583774", "3013964848", "2428983", "3008881803", "3003749961", "3006975482", "3006750986", "2183887", "3038141559", "3006697241", "1528440", "1831750", "2020676", "8022103", "3011537487", "8022752", "3005878604", "1721113", "1824206", "3014101053", "3011659880", "3009238346", "3007662999", "3033849261", "3008975187", "3017844600", "3007515312", "3007123908", "3009171220", "3042991836", "3008434522" ], "fei_number": [ "1000115792", "3020460367", "3003674698", "1000122527", "3007912863", "3013856565", "2024242", "3027332478", "2183191", "3007744192", "1043549", "3027847726", "3031582440", "3038197284", "3004198457", "3002818647", "3045978136", "3004499949", "3006554924", "3002572935", "1523574", "3042262500", "3007836437", "1000143830", "3001947547", "3006157842", "3006513362", "3010509576", "3008058231", "3006897996", "3002668219", "3006891315", "3026311463", "3005206084", "3000134760", "3009567010", "3030488262", "3014270896", "3017421556", "3031563141", "3043654660", "3015223105", "3020978037", "3017181414", "3007420694", "3006554931", "2427360", "2518443", "1000118429", "3016678414", "3017884063", "3021559257", "3012330365", "3017708892", "1000122786", "3007802293", "3006123327", "3013408788", "3003770834", "3010373263", "3006342679", "3011574775", "3008042739", "3014739961", "3011719874", "3009222501", "1000211739", "3003769112", "3045752744", "3004574120", "3011910987", "1841", "3037012186", "1033902", "3030927791", "3010703925", "3005706637", "3005070829", "3008386649", "3002913923", "3009688852", "3007583774", "3013964848", "3002808508", "3008881803", "3003749961", "3006975482", "3006750986", "2183887", "3038141559", "1000125727", "3006697241", "1831750", "2020676", "3011537487", "3005878604", "1721113", "1824206", "3014101053", "3011659880", "3009238346", "3007662999", "3033849261", "3008975187", "3017844600", "3007515312", "3007123908", "3009171220", "3042991836", "3008434522" ], "device_name": "Stretcher, Wheeled", "medical_specialty_description": "General Hospital", "regulation_number": "880.6910", "device_class": "2" } } ] }