{ "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": "215068", "product_res_number": "Z-2620-2025", "event_date_initiated": "2025-07-15", "event_date_posted": "2025-09-24", "recall_status": "Open, Classified", "res_event_number": "97285", "product_code": "FSY", "product_description": "Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034", "code_info": "UDI-DI: 07613327296167 and 07613327651317\nREF/Serial Numbers:\nCH00000001/7000010116, 7000010117, 7000010118, 7000010119, 7000010120, 7000010121, 7000010122, 7000010123, 7000010124, 7000010125, 7000010141, 7000010142, 7000010177, 7000010178, 7000010148, 7000010149, 7000010157, 7000010137, 7000010175, 7000010176, 7000010145, 7000010146, 7000010147, 7000010309, 7000010305, 7000010307, 7000010296, 7000010143, 7000010150, 7000010151, 7000010155.\n\nP60034/1000022, 1000023, 1000024, 1000016, 1000017, 1000018, 1000019, 1000020, 1000021", "firm_fei_number": "3002975342", "recalling_firm": "Stryker Communications", "address_1": "571 Silveron Blvd", "city": "Flower Mound", "state": "TX", "postal_code": "75028", "additional_info_contact": "972-410-7100", "reason_for_recall": "Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.", "root_cause_description": "Component change control", "action": "On 7/15/2025, recall notices were mailed or hand delivered to customers who were asked to do the following: \n\nInform individuals within your organization who need to be aware of this action.\n2. A Stryker representative will be in contact with your account to schedule a field service visit at your earliest convenience to complete the following:\na. Deinstall impacted Oculan light(s) and reinstall with SLX lights to ensure your operating room stays in use.\nb. Upon product remediation and availability, Stryker will return to reinstall Oculan within your operating room(s). Your local Stryker representative will provide timing updates as they are available.\n3. Complete and return the Business Reply Form to CommunicationsRA1@stryker.com\n4. Maintain awareness of this communication internally until all required actions have been completed within your facility.", "product_quantity": "40", "distribution_pattern": "US Nationwide distribution in the states of TX, IL, NY, UT, OR, AZ, VT, NY, IL, MN.", "openfda": { "k_number": [ "K954169", "K101537", "K901830", "K010716", "K860739", "K896674", "K820681", "K140460", "K093009", "K854922", "K961843", "K922836", "K090378", "K002463", "K900211", "K904965", "K083066", "K132551", "K061317", "K140930", "K042395", "K974433", "K132747", "K963682", "K142076", "K984611", "K040735", "K030906", "K914076", "K000639", "K132307", "K142984", "K990656", "K891756", "K973466", "K891757", "K902864", "K993242", "K100702", "K892808", "K943288", "K060802", "K944855", "K083323", "K122875", "K140812", "K771865", "K040015", "K991527", "K031068", "K063333", "K070442", "K042382", "K974084", "K021585", "K071698", "K140461", "K992090", "K781887", "K873786", "K965130", "K024132", "K780666", "K011693", "K072072", "K102758", "K982063", "K915285", "K080857", "K093010", "K131893", "K120392", "K981081", "K031979" ], "registration_number": [ "3003574554", "3031563141", "1836161", "3017970309", "3029936435", "3023808059", "1043572", "3012092534", "3009028104", "3033527731", "3030516433", "3012272052", "1054713", "3015468226", "3030558088", "3044829820", "3010726901", "3005698350", "1066635", "3035641086", "9617655", "3012165496", "1066270", "3011574775", "3015131225", "3042992004", "3006437518", "3031700059", "3010041511", "1000122786", "3042970964", "9710585", "3042991836", "3011580044", "9681407", "1017294", "3007682310", "9710098", "3011137372", "9611503", "9612030", "1225473", "3011644607", "3027847726", "3020703842", "1423537", "8010153", "3009542956", "3021839632", "3029970239", "3002821232", "3025628903", "2031963", "3026390991", "3009061550", "9680506", "3015223105", "3000286616", "3007238566", "1825014", "3007143268", "3009129579", "1921846", "9710055", "3002532594", "3011910987", "3006223081" ], "fei_number": [ "3003574554", "3002975342", "3031563141", "1000182014", "3017970309", "3029936435", "3003184737", "3023808059", "3000957797", "1043572", "1000125341", "3003779679", "3009028104", "3033527731", "3030516433", "3012272052", "3015468226", "3030558088", "3002806934", "3044829820", "3010726901", "3005698350", "3002808335", "3035641086", "3012165496", "3011574775", "3015131225", "3042992004", "3001237319", "3006437518", "3010041511", "3031700059", "3042970964", "1000122786", "3042991836", "3011580044", "3005747797", "1000396729", "1017294", "1000114111", "3002957101", "3011644607", "3027847726", "3002750084", "3006125657", "1000214453", "3020703842", "3029970239", "3002939620", "3009542956", "3002821232", "3025628903", "3026390991", "3009061550", "3015223105", "3000286616", "3007238566", "3001236905", "1825014", "3009129579", "3025504317", "1921846", "3007143268", "3002532594", "3011910987", "3002465150", "3006223081" ], "device_name": "Light, Surgical, Ceiling Mounted", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4580", "device_class": "2" } } ] }