{ "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": "203916", "product_res_number": "Z-0424-2024", "event_date_initiated": "2023-08-30", "event_date_posted": "2023-12-01", "recall_status": "Open, Classified", "res_event_number": "93317", "product_code": "FNL", "product_description": "ProCuity bed series, model number 3009, item number: 300900000000,", "code_info": "UDI-DI (GTIN): 07613327512656. \nSerial numbers: 2207000698, 2207000676, 2207000619, 2206001100, 2206001090, 2206001089, 2206001086, 2206001084, 2208001745, 2208001734, 2208001725, 2208001724, 2208000397, 2208000394, 2208000032, 2209002157, 2209002158, 2209002165, 2210000711 , 2210000721 , 2210000723 , 2111000494 , 2206001248 , 2206001250 , 2206001265 , 2206001273 , 2206001317 , 2207000023 , 2207000078 , 2207000303 , 2207000307 , 2207000342 , 2207000350 , 2207000353 , 2207000358 , 2110002355 , 2108002264 , 2209000269 , 2106002756 , 2103001270 , 2109000898 , 2109001004 , 2108001784 , 2107001856 , 2208000874 , 2208000873 , 2208000814 , 2208000805 , 2104001582 , 2104003135 , 2104003758 , 2104003772 , 2104003778 , 2104003786 , 2104003798 , 2104004415 , 2104004431 , 2104004441 , 2104004491 , 2104004537 , 2104004993 , 2104004997 , 2104004998 , 2104005012 , 2104005013 , 2105000649 , 2105000657 , 2105001594 , 2105001621 , 2107000100 , 2107000102 , 2208000795 , 2108000833 , 2211004443, 2211004441, 2211004293, 2211004095 , 2211004050 , 2211003541 , 2209002035 , 2205000370 , 2208001249 , 2208001250 , 2202001692 , 2108002072 , 2108002161 , 2202001958 , 2202002003 , 2205000361 , 2109001797 , 2208001175 , 2208001162 , 2208001044 , 2107001827 , 2208000995 , 2208000992 , 2208000980 , 2208000910 , 2208000854 , 2201001114 , 2208001148 , 2208001129 , 2207001981 , 2106001072 , 2206001367 , 2209002143 , 2208000569 , 2208000568 , 2208000507 , 2208000473 , 2109002479 , 2210002762 , 2112002175 , 2112001663 , 2112000049 , 2106002744 , 2109003074 , 2110000077 , 2110000082 , 2105000094 , 2105004609 , 2108000595 , 2104000805 , 2108001834 , 2108001836 , 2208000577 , 2208000496 , 2201000319 , 2203002461 , 2108002656 , 2203001282 , 2109001070 , 2209002133 , 2112002188 , 2112001020 , 2211000729 , 2109002517 , 2103003835 , 2104000245 , 2207001763 , 2107000933 , 2102000258 , 2110000967 , 2110000965 , 2103000446 , 2108002753 , 2108002726 , 2108002685 , 2108002683 , 2108002673 , 2108002556 , 2108002533 , 2108002507 , 2105002810 , 2112000853 , 2105002764 , 2107000759 , 2209000686 , 2108001946 , 2108001932 , 2112001628 , 2111000528 , 2110001582 , 2111000399 , 2111000286 , 2111000092 , 2111001950 , 2110002881 , 2110002369 , 2207000860 , 2207000862 , 2109002846 , 2110002291 , 2110001555 , 2110001362 , 2108002306 , 2201000283 , 2108001939 , 2107001826 , 2210000028 , 2210000004 , 2111000392 , 2110002880 , 2110002867 , 2110000448 , 2110000458 , 2110002828 , 2110002819 , 2110002405 , 2110002399 , 2110001809 , 2101002085 , 2109002376 , 2110001384 , 2110002668 , 2111000409 , 2111000533 , 2112000343 , 2112000347 , 2109002824 , 2209002123 , 2208000334 , 2208000331 , 2107000836 , 2212000241 , 2212000236, 2212000223, 2212000217 , 2212000215 , 2208000075 , 2201000857 , 2108001491 , 2108001490 , 2108000825 , 2009000613 , 2106001220 , 2106001200 , 2106001197 , 2104001603 , 2201000196 , 2208001930 , 2208001924 , 2208001886 , 2210002945 , 2208001860 , 2111000090 , 2107001825 , 2109002592 , 2107000127 , 2107000115 , 2105002209 , 2205000426 , 2107001697 , 2202001129 , 2105002197 , 2105002192", "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": "Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.", "root_cause_description": "Process control", "action": "A customer notification was sent October 20, 2023 via FedEx. Users are to (1) Locate affected units and identify the address where they can be serviced. (2) Return the business reply form by fax +1 269 488-8691 or email to productfieldaction@stryker.com. Upon receipt of the completed business reply form, Stryker will contact you to arrange a time to complete the required electrical tests. (3) Forward notification to any new user/location and advise Stryker of the new address or device status if disposed of or obsolete using the reply form. Address questions or concerns to Customer Service at +1 800 327-0770 Monday through Friday from 8:00 a.m. to 6:00 p.m. ET.", "distribution_pattern": "Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.", "openfda": { "k_number": [ "K821185", "K974296", "K843781", "K911893", "K903904", "K864186", "K945664", "K852674", "K902183", "K925534", "K922352", "K935837", "K951514", "K881844", "K881960", "K962250", "K831821", "K925576", "K890426", "K964515", "K875037", "K872924", "K972115", "K971546", "K982783", "K915437", "K853270", "K202964", "K931482", "K951735", "K872925", "K830559", "K932663", "K900151", "K945042", "K780371", "K854832", "K894296", "K962942", "K881782", "K811897", "K926435", "K864172", "K930703", "K881027", "K103536", "K890845", "K873291", "K883463", "K854867", "K951161", "K931581", "K872923", "K974254", "K790049", "K893745", "K946149", "K890293", "K964246", "K963701", "K851551", "K934090", "K930234", 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