{ "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": "219749", "product_res_number": "Z-2449-2026", "event_date_initiated": "2026-05-15", "event_date_posted": "2026-06-15", "recall_status": "Open, Classified", "res_event_number": "98768", "product_code": "FSY", "product_description": "HarmonyAIR A-Series Surgical Lighting System", "code_info": "UDIs: 00724995185947, 00724995186418, 00724995187156, 00724995188009, 00724995188498, 00724995189198, 00724995185954, 00724995186425, 00724995187170, 00724995188016 00724995188504, 00724995189211, 00724995185961, 00724995186432, 00724995187187 00724995188047, 00724995188535, 00724995189228, 00724995185978, 00724995186548 00724995187217, 00724995188054, 00724995188542, 00724995189280,00724995185985, 00724995186555, 00724995187248, 00724995188078, 00724995188580, 00724995189372, 00724995186067, 00724995186562, 00724995187262, 00724995188122, 00724995188597, 00724995189419, 00724995186074, 00724995186579, 00724995187279, 00724995188221, 00724995188603, 00724995189990, 00724995186081, 00724995186593, 00724995187286, 00724995188238, 00724995188610, 00724995190002, 00724995186098, 00724995186616, 00724995187347, 00724995188245, 00724995188627, 00724995190033, 00724995186111, 00724995186623, 00724995187378, 00724995188252, 00724995188634, 00724995190040, 00724995186128, 00724995186661, 00724995187385, 00724995188269, 00724995188641, 00724995190354, 00724995186135, 00724995186678, 00724995187415, 00724995188276, 00724995188658, 00724995190361, 00724995186203, 00724995186685, 00724995187453, 00724995188283, 00724995188665, 00724995199364, 00724995186302, 00724995186692, 00724995187484, 00724995188290, 00724995188672, 00724995199913, 00724995186319, 00724995186722, 00724995187538, 00724995188306, 00724995188689, 00724995199944, 00724995186326, 00724995186739, 00724995187569, 00724995188313, 00724995188702, 00724995200480, 00724995186333, 00724995186746, 00724995187576, 00724995188320, 00724995188726, 00724995200886, 00724995186340, 00724995186753, 00724995187583, 00724995188337, 00724995188849, 00724995200909,00724995186357, 00724995186760, 00724995187606, 00724995188344, 00724995188948, 00724995200930, 00724995186364, 00724995186784, 00724995187620, 00724995188375, 00724995189068, 00724995200947, 00724995186371, 00724995186807, 00724995187712, 00724995188412, 00724995189075, 00724995200961, 00724995186388, 00724995186906, 00724995187729, 00724995188467, 00724995189105, 00724995201074, 00724995186395, 00724995187125, 00724995187989, 00724995188474, 00724995189136, 00724995217372, 00724995186401, 00724995187149, 00724995187996, 00724995188481, 00724995189181, 00724995222970", "firm_fei_number": "1527821", "recalling_firm": "Steris Corporation", "address_1": "5960 Heisley Rd", "city": "Mentor", "state": "OH", "postal_code": "44060-1834", "additional_info_contact": "Michelle LaVan\n440-2597417", "reason_for_recall": "The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.", "root_cause_description": "Material/Component Contamination", "action": "An URGENT MEDICAL DEVICE RECALL notification letter dated 5/1/26 was sent to customers.\n\nSTERIS Action All affected Customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their lighting system(s) to perform the correction as soon as possible.\nFor the paint issue, each affected lighting system will undergo a full visual inspection for any signs of paint delamination; as needed a service kit will be installed to prevent paint chipping from occurring or if deemed necessary replaced.\nFor the button issue, each affected lighting system will undergo inspection for any signs of potential separation from the light head and handle. Buttons failing this inspection will be replaced.\nUser Action Users can continue to use their lighting system(s) prior to completion of the correction. Users are reminded to ensure no excess fluids remain on light head during or after cleaning, per the Operator Manuals. Should any issues be observed prior to the correction being completed, users should submit a complaint by contacting STERIS Customer Service at 1-800-548-4873.\nUsers are also reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact your local Account Manager.", "product_quantity": "2101 units", "distribution_pattern": "Worldwide - US Nationwide distribution.", "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" } } ] }