{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "114391", "product_res_number": "Z-0454-2013", "event_date_initiated": "2011-05-24", "event_date_posted": "2012-12-03", "recall_status": "Terminated", "event_date_terminated": "2014-05-28", "res_event_number": "63634", "product_code": "JCX", "product_description": "Neptune 2 Rover - ULTRA ~120V ~ 60 Hz 12A\r\nREF 0702-001-000, Rx, Caution, consult accompanying documents\r\nConsult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, \r\nThe Neptune Waste Management System consists of a mobile rover unit\r\nused to suction and collect fluid waste, small debris and electrocautery\r\nsmoke from a surgical site. Mobility allows the rover unit to be\r\nrelocated to a waste disposal area where the rovers collection canisters\r\ncan be emptied, via the docking station.\r\n\r\nIntended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.", "code_info": "Part 0702-001-000 (120v)   Lot 0733700353 through 1036100423", "firm_fei_number": "1811755", "recalling_firm": "Stryker Instruments Div. of Stryker Corporation", "address_1": "4100 E Milham Ave", "city": "Portage", "state": "MI", "postal_code": "49002-9704", "additional_info_contact": "K. Kelly Smith\n269-389-3584", "reason_for_recall": "Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, due to multiple exposures resulting in back pain.", "root_cause_description": "Component design/selection", "action": "Stryker Instruments sent a \"STRYKER NEPTUNE 2 ULTRA 120V & 230V WASTE MANAGEMENT SYSTEM\" letter dated June 22, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Reply Form via fax to Stryker at 269-906-9121 or email to sales.service@stryker.com. Technical questions should be addressed to Neptune Field Service at 800-800-4236 ext. 5052.", "product_quantity": "5865", "distribution_pattern": "Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan.", "openfda": { "k_number": [ "K042349", "K140809", "K102626", "K162421", "K791210", "K771071", "K914694", "K120065", "K920288", "K791238", "K944119", "K791241", "K974038", "K930030", "K011725", "K792592", "K082762", "K843081", "K820330", "K080845", "K222552", "K190105", "K832301", "K063448", "K122756", "K181398", "K243638", "K132671", "K251111", "K941526", "K131099", "K801043", "K182950", "K900430", "K872094", "K920287", "K950698", "K190789", "K132308", "K133786", "K842050", "K090759", "K180115", "K103535", "K914177", "K941525", "K233428", "K963558", "K930852", "K133196", "K791239", "K060277", "K080005", "K130001", "K123188", "K941527", "K801349", "K820331", "K081047", "K895761", "K930900", "K140031", "K841538", "K153407", "K791240", "K001716", "K945062", "K982304", "K941524", "K250964", "K935218", "K161358", "K841160", "K172481", "K940886", "K112421", "K243418" ], "registration_number": [ "", "3005168196", "2029214", "3011683674", "1055236", "3004112621", "3011418975", "3021009035", "3033509898", "9616843", "2022724", "1317202", "2515872", "3006789357", "3003595343", "1924066", "3032391", "3006446479", "3003627840", "3015615738", "2431273", "3012316249", "3030733800", "3007682555", "3036756245", "3013758550", "2249651", "3006395447", "3015207155", "3003144120", "1043214", "3007127244", "3016678045", "2225311", "3008220943", "3004598644", "3015542154", "1054241", "2320762", "3007997036", "3047841690", "8022210", "3013556777", "3014590707", "3012497308", "1526350", "3003803075", "3003542872", "3006535925", "3013666218", "3015967359", "3016591327", "2031894", "3006142527", "3021244152", "9611102", "3010079067", "3010399798", "3012494290", "3008363932", "3014810929", "9611665", "2246552", "3025603301", "3010834934", "3004993040", "3015550451" ], "fei_number": [ "", "3005168196", "3011683674", "3004112621", "3011418975", "3021009035", "3033509898", "2022724", "3004099094", "1317202", "2515872", "3006789357", "3003595343", "1924066", "3002299608", "3006446479", "3003627840", "3015615738", "2431273", "3012316249", "3030733800", "3007682555", "3036756245", "3013758550", "3006395447", "3001099558", "3015207155", "1000112968", "1043214", "3007127244", "3002807095", "3016678045", "2225311", "3002771993", "3008220943", "3004598644", "3015542154", "3932", "3007997036", "3047841690", "1000112877", "3013556777", "3014590707", "3012497308", "1526350", "3003803075", "3003542872", "3006535925", "1000220862", "3013666218", "3015967359", "3016591327", "3003188183", "3006142527", "3021244152", "3010079067", "3010399798", "3012494290", "3008363932", "3002808001", "3014810929", "2246552", "3025603301", "3010834934", "3003040625", "3004993040", "3015550451" ], "device_name": "Apparatus, Suction, Ward Use, Portable, Ac-Powered", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4780", "device_class": "2" } } ] }