{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "197083", "product_res_number": "Z-0479-2023", "event_date_initiated": "2022-11-11", "event_date_posted": "2022-12-14", "recall_status": "Open, Classified", "res_event_number": "91160", "product_code": "FPO", "product_description": "Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)", "code_info": "UDI-DI (GTIN) 07613327504460 \n\nSerial Numbers\n2204000343 \n2204000345 \n2204000348 \n2204000351 \n2204000369 \n2204000370 \n2204000382 \n2204000430 \n2204000673 \n2204000682 \n2205000094 \n2205000095 \n2205000096 \n2205000097 \n2205000098 \n2205000099 \n2205000100 \n2205000101 \n2205000102 \n2205000104 \n2205000105 \n2205000109 \n2205000110 \n2205000111 \n2205000113 \n2205000115 \n2205000117 \n2205000119 \n2205000123 \n2205000124 \n2205000125 \n2205000128 \n2205000129 \n2205000130 \n2205000132 \n2205000135 \n2205000137 \n2205000139 \n2205000142 \n2205000143 \n2205000151 \n2205000170 \n2208001658 \n2208001660 \n2203001748 \n2204000431 \n2204000651 \n2204000663 \n2204000665 \n2204000667 \n2204000670 \n2204000671 \n2204000680 \n2203001948 \n2203001955 \n2204000075 \n2204000094 \n2204000097 \n2204000632 \n2204000633 \n2204000635 \n2204000637 \n2204000647 \n2204000676 \n2204000683 \n2202001579 \n2202001585 \n2203002650 \n2203002651 \n2203002652 \n2203002653 \n2203002654 \n2203002666 \n2204000077 \n2204000078 \n2204000086 \n2112001508 \n2204000681 \n2204000684 \n2203001720 \n2203001925 \n2203001928 \n2203001929 \n2203001932 \n2203002660 \n2203002664 \n2203002665 \n2204000080 \n2204000084 \n2204000089 \n2204000105 \n2204000112 \n2204000675 \n2202001560 \n2202001593 \n2202001594 \n2203001721 \n2203001723 \n2203001744 \n2203001926 \n2203001931 \n2203001945 \n2203002663 \n2204000074 \n2204000076 \n2204000085 \n2204000092 \n2204000109 \n2204000114 \n2204000116 \n2204000117 \n2204000118 \n2204000269 \n2204000271 \n2204000273 \n2204000274 \n2204000275 \n2204000279 \n2204000282 \n2204000283 \n2204000284 \n2204000285 \n2204000286 \n2204000287 \n2204000288 \n2204000289 \n2204000290 \n2204000291 \n2204000292 \n2204000346 \n2204000352 \n2204000381 \n2204000408 \n2204000429 \n2204000433 \n2204000452 \n2204000453 \n2204000636 \n2204000638 \n2204000639 \n2204000640 \n2204000641 \n2204000643 \n2204000645 \n2204000648 \n2204000649 \n2204000652 \n2204000653 \n2204000655 \n2204000656 \n2204000657 \n2204000658 \n2204000662 \n2205000141 \n2204000277 \n2112001535 \n2204000103 \n2202001299 \n2202001314 \n2202001315 \n2202001523 \n2202001539 \n2202001541 \n2202001570 \n2202001572 \n2202001592 \n2204000081 \n2204000098 \n2204000272 \n2202000816 \n2203001944 \n2203001937 \n2203001947 \n2203001934 \n2203001954 \n2204000276 \n2202001580 \n2204000082 \n2204000093 \n2204000646 \n2204000654 \n2204000659 \n2204000661 \n2204000664 \n2204000666 \n2204000677 \n2204000678 \n2204000686 \n2202001535 \n2202001555 \n2202001556 \n2202001565 \n2202001573 \n2202001312 \n2204000294 \n2204000311 \n2202000802 \n2112001492 \n2203002657 \n2202001574 \n2202000811 \n2112001504 \n2202001303 \n2202000797 \n2202001307 \n2203001953 \n2204000293 \n2202000820 \n2202000485 \n2202000478 \n2112001511 \n2202000819 \n2204000309 \n2112001512 \n2112001490 \n2203002658 \n2202000481 \n2202000805 \n2202001300 \n2202000475 \n2112001514 \n2202000824 \n2202000487 \n2202000812 \n2112001526 \n2202000826 \n2112001513 \n2112001521 \n2203001940 \n2112001494 \n2112001529 \n2202000801 \n2202001519 \n2202001309 \n2112001518 \n2203002668 \n2112001520 \n2112001536 \n2203001949 \n2202000480 \n2112001525 \n2204000300 \n2202000807 \n2202000482 \n2112001491 \n2112001496 \n2112001528 \n2202001521 \n2112001517 \n2204000310 \n2202000804 \n2202000477 \n2202000821 \n2202001317 \n2203001956 \n2202000809 \n2204000295 \n2112001485 \n2204000299 \n2203002655 \n2204000099 \n2202001554 \n2112001519 \n2203002659 \n2202001304 \n2202000483 \n2202000803 \n2202001302 \n2112001503 \n2203001930 \n2202000490 \n2202001318 \n2202001308 \n2112001522 \n2112001515 \n2203002667 \n2202001578 \n2112001495 \n2202001316 \n2112001527 \n2112001501 \n2112001534 \n2112001524 \n2202000823 \n2204000304 \n2202000817 \n2112001488 \n2202000800 \n2112001523 \n2202001306 \n2202000476 \n2202001311 \n2202000473 \n2202001301 \n2112001493 \n2202000806 \n2204000308 \n2204000296 \n2112001516 \n2202000479 \n2112001489 \n2202000815 \n2202000474 \n2202000492 \n2203002669 \n2202001313 \n2112001530 \n2112001532 \n2204000302 \n2202000822 \n2202001518 \n2112001533 \n\n2204000327 \n2204000328 \n2204000329 \n2204000330 \n2204000331 \n2204000332 \n2112001509 \n2202000488 \n2202000489 \n2202000808 \n2202000810 \n2202000813 \n2203001941 \n2203001942 \n2203001943 \n2203001951 \n2204000340 \n2204000634 \n2204000642 \n2204000644 \n2204000650 \n2203002386 \n2203002387 \n2203002388 \n2203002389 \n2203002390 \n2203002391 \n2203002392 \n2203002393 \n2203002394 \n2203002395 \n2203002408 \n2203002409 \n2203002410 \n2203002411 \n2203002412 \n2203002413 \n2203002414 \n2203002415 \n2203002416 \n2203002417 \n2203002418 \n2208002581 \n2208002582 \n2208002583 \n2208002584 \n2208002585 \n2208002586 \n2208002587 \n2208002588 \n2208002589 \n2208002590 \n2208002591 \n2208002592 \n2208002593 \n2208002594 \n2208002595 \n2208002596 \n2208002597 \n2208002598 \n2208002599 \n2203002406", "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": "Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected.", "root_cause_description": "Under Investigation by firm", "action": "On November 11, 2022, the firm notified affected customers via \"URGENT: \nMEDICAL DEVICE CORRECTION\" letters. Devices require servicing. Customers were instructed to locate affected units and identify the address where they can be serviced. Until servicing can be performed, customers were provided with additional instructions and precautions to follow to ensure safe continued use of the device. Return the enclosed business reply form to confirm receipt of this notification by fax +1 269 488 8691 or email productfieldaction@stryker.com. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the modification/repair of your Power-PRO 2. If you have loaned or sold 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.\n\nIf you have any questions 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": "465 (403 US; 62 OUS)", "distribution_pattern": "Worldwide Distribution: US (Nationwide) and Foreign to countries of: Australia, Canada, Netherlands, and United Kingdom.", "openfda": { "k_number": [ "K902503", "K072598", "K843439", "K884759", "K761147", "K840124", "K942948", "K946101", "K895740", "K932260", "K853421", "K904011", "K873181", "K943262", "K922808", "K935297", "K943529", "K862959", "K862441", "K792570", "K861410", "K920704", "K840920", "K900872", "K840125", "K871556", "K113598", "K840122", "K952447", "K914543", "K874332", "K962181", "K801935", "K972528", "K955766", "K863083", "K881845", "K923730", "K922809", "K854304", "K961437", "K864269", "K933366", "K943528", "K933060", "K945431", "K943864", "K943969", "K844578", "K933071" ], "registration_number": [ "3008386649", "3011537487", "3008058231", "2183887", "3006342679", "2020676", "3008881803", "3007836437", "2518443", "8022103", "3005070829", "3021559257", "3004198457", "3006750986", "3042991836", "3011719874", "3027332478", "3007420694", "3020460367", "2183191", "3002818647", "3017884063", "3030927791", "3006975482", "3009171220", "2428983", "3004499949", "3003749961", "3007123908", "3011910987", "3010509576", "3013964848", "8010652", "3033849261", "3042262500", "3006554924", "3026311463", "3020978037", "3017421556", "3011574775", "3006554931", "1033902", "3001947547", "3008975187", "1931947", "3027847726", "3003770834", "3017181414", "3014739961", "3006123327", "1824206", "2184033", "9613910", "3014270896", "8030903", "3009567010", "9681454", "2027797", "1523574", "1831750", "2024242", "3007912863", "3038141559", "3005878604", "3006891315", "3009238346", "3005206084", "3017844600", "3017708892", "8022752", "3016678414", "3015223105", "3013856565", "3045752744", "3008434522", "1528440", "3006157842", "3005706637", "3008042739", "3031563141", "1043549", "3013408788", "3007515312", "3037012186", "3007583774", "3038197284", "3030488262", "3031582440", "1000211739", "3006513362", "3006897996", "3012330365", "3007744192", "3014101053", "1000122786", "3010703925", "1721113", "3010373263", "3007802293", "3045978136", "3009688852", "3009222501", "3007662999", "3043654660", "3011659880", "3002668219", "3003674698", "9615386", "3006697241", "1422399" ], "fei_number": [ "3008386649", "3011537487", "3008058231", "1000143830", "2183887", "3006342679", "2020676", "3008881803", "3007836437", "2518443", "1000125727", "3005070829", "3021559257", "3004198457", "3006750986", "3004574120", "3042991836", "3011719874", "3027332478", "3007420694", "3020460367", "2183191", "3002818647", "1000118429", "3017884063", "3030927791", "3006975482", "3009171220", "3004499949", "3003749961", "3007123908", "3011910987", "3010509576", "3013964848", "1841", "3033849261", "3042262500", "3006554924", "3026311463", "3020978037", "3017421556", "3011574775", "3006554931", "1033902", "3001947547", "2427360", "3008975187", "3000134760", "3027847726", "3003770834", "3017181414", "3014739961", "1000115792", "3006123327", "1824206", "3014270896", "3009567010", "3002913923", "1523574", "3002572935", "1831750", "2024242", "3002808508", "3007912863", "3038141559", "3005878604", "3006891315", "3009238346", "3005206084", "3017844600", "3017708892", "3016678414", "3015223105", "3013856565", "3045752744", "3008434522", "3006157842", "3005706637", "3008042739", "3031563141", "3003769112", "1043549", "3013408788", "3007515312", "3037012186", "3007583774", "3038197284", "3030488262", "3031582440", "1000211739", "3006513362", "3006897996", "3012330365", "3007744192", "3014101053", "1000122786", "3010703925", "1721113", "3010373263", "3007802293", "3045978136", "3009688852", "3009222501", "3007662999", "1000122527", "3043654660", "3011659880", "3002668219", "3003674698", "3006697241" ], "device_name": "Stretcher, Wheeled", "medical_specialty_description": "General Hospital", "regulation_number": "880.6910", "device_class": "2" } } ] }