{ "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": 2 } }, "results": [ { "cfres_id": "174896", "product_res_number": "Z-2539-2019", "event_date_initiated": "2019-03-22", "event_date_created": "2019-09-12", "recall_status": "Open, Classified", "res_event_number": "83355", "product_code": "FSY", "product_description": "Berchtold Chromophare F528 Surgical Lights.\n\nProduct Usage: \nThe medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.", "code_info": "Serial number ranges: 83180-69712678 to 83180-88970377;", "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. Jennifer S. Harris\n469-470-4316", "reason_for_recall": "The back cover of the light head was insufficiently assembled and could potentially fall off the light.", "root_cause_description": "Employee error", "action": "The recalling firm issued letters via FedEx on 3/22/2019 to their U.S. consignees. The recall letter identified the affected product, problem and actions to be taken. ,The letter instructs the customer to disseminate it within their organization and that a Stryker representative will begin replacements for customer facilities in January. For the replacement, the Stryker representative will perform an onsite rework of the light head cover. In the meantime, the lights can continue to remain in full use.\n\nA response form was enclosed for the customer to indicate they have read and understood the instructions. The form was to be returned via email. The recalling firm's representatives will contact the customer to schedule an inspection of their light and will track completion of the visits and inspections.", "product_quantity": "946 lights", "distribution_pattern": "Distribution was nationwide, including to Puerto Rico. There was also government/military distribution.\n\nForeign distribution was made to Argentina, Austria, Australia, Belgium, Bulgaria, Canada, China, Colombia, Denmark, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Kazakhstan, Korea, Kuwait, Lithuania, Mexico, Netherlands, Philippines, Poland, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.", "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" } } ] }