{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "171670", "product_res_number": "Z-1388-2019", "event_date_initiated": "2018-11-13", "event_date_created": "2019-05-21", "recall_status": "Open, Classified", "res_event_number": "82476", "product_code": "FSY", "k_numbers": [ "K060802" ], "product_description": "EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light Suspension, Central Axis, FP/5P/5P; 0682001432, EDS Light Suspension, Central Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P.\n\nProduct Usage:\nThe lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.", "code_info": "Serial numbers 100000000065406 to 100000000106685.", "firm_fei_number": "3002975342", "recalling_firm": "Stryker Communications", "address_1": "571 Silveron Blvd", "city": "Flower Mound", "state": "TX", "postal_code": "75028", "additional_info_contact": "Ms. Julie Baker\n972-834-8656", "reason_for_recall": "There is a potential the joint in the suspension of the device is insufficiently assembled.", "root_cause_description": "Employee error", "action": "The recalling firm issued letters dated 11/13/2018 via FedEx informing to customers. The letter identified the affected product problem and actions to be taken. The customer is asked to disseminate the information within their organization. A response form was enclosed to indicate the customer has read and understands the instructions in the letter. The form was to be returned to the recalling firm via email. Customer was notified that a Stryker representative will begin visiting customer facilities in November to inspect their equipment. For questions contact\n\" Stryker Technical Support at (800) 243-5135 or comm.techservices@stryker.com", "product_quantity": "3,176 devices", "distribution_pattern": "Distribution was nationwide, including Puerto Rico. There was also government/military distribution.\n\nForeign distribution was made to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, France, India, Japan, Korea, Mexico, Netherlands, Spain and United Kingdom.", "openfda": { "k_number": [ "K122875", "K093009", "K072072", "K040015", "K120392", "K142984", "K992090", "K071698", "K902864", "K990656", "K922836", "K943288", "K944855", "K771865", "K974084", "K042382", "K965130", "K860739", "K891757", "K102758", "K002463", "K915285", "K000639", "K891756", "K040735", "K781887", "K954169", "K820681", "K904965", "K090378", "K031068", "K083323", "K100702", "K142076", "K140930", "K060802", "K070442", "K010716", "K984611", "K140812", "K991527", "K140460", "K101537", "K080857", "K030906", "K042395", "K132307", "K854922", "K901830", "K024132", "K982063", "K031979", "K873786", "K011693", "K021585", "K993242", "K963682", "K974433", "K892808", "K896674", "K140461", "K914076", "K061317", "K063333", "K131893", "K961843", "K083066", "K780666", "K132747", "K093010", "K900211", "K981081", "K132551", "K973466" ], "registration_number": [ "3015468226", "3002532594", "3026390991", "3021839632", "3011137372", "3012165496", "3012092534", "3035641086", "1017294", "9612030", "3009542956", "3011910987", "1066635", "1423537", "1825014", "9617655", "3003574554", "3020703842", "3007238566", "1066270", "3023808059", "3030558088", "1225473", "3029970239", "3025628903", "3007682310", "3017970309", "3031563141", "9710098", "9710055", "3015131225", "3030516433", "3015223105", "3009061550", "3010726901", "3011574775", "1000122786", "3007143268", "3029936435", "3012272052", "1043572", "3042970964", "3033527731", "9611503", "9681407", "3005698350", "1054713", "9680506", "3011644607", "3000286616", "3006437518", "3009028104", "3042991836", "8010153", "3027847726", "3009129579", "3002821232", "3011580044", "3006223081", "1836161", "3031700059", "3010041511", "2031963", "9710585", "1921846", "3044829820", "3042992004" ], "fei_number": [ "3015468226", "3002532594", "3026390991", "3002975342", "3002806934", "3012165496", "3002465150", "3035641086", "1017294", "3009542956", "3005747797", "3011910987", "1825014", "3002750084", "3003574554", "3020703842", "3007238566", "1000114111", "3023808059", "3030558088", "3029970239", "3025628903", "3017970309", "3031563141", "3015131225", "1000125341", "3015223105", "3030516433", "3009061550", "3010726901", "3011574775", "1000122786", "3003779679", "3007143268", "3029936435", "3012272052", "1043572", "1000182014", "3042970964", "3033527731", "3005698350", "3001237319", "3002939620", "1000214453", "3042992004", "3006437518", "3011644607", "3000286616", "3003184737", "3009028104", "3042991836", "3025504317", "3002808335", "3006125657", "3001236905", "3009129579", "3002821232", "3027847726", "3011580044", "3006223081", "3031700059", "3010041511", "1000396729", "1921846", "3044829820", "3000957797", "3002957101" ], "device_name": "Light, Surgical, Ceiling Mounted", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4580", "device_class": "2" } } ] }