{ "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": 2 } }, "results": [ { "cfres_id": "214408", "product_res_number": "Z-2177-2025", "event_date_initiated": "2025-06-23", "event_date_posted": "2025-07-25", "recall_status": "Open, Classified", "res_event_number": "97068", "product_code": "FSY", "product_description": "Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems", "code_info": "UDI: 00724995203245: Serial Numbers: 0400224028, 0401625167, 0401625171, 0401625180, 0401625185, 0401625190, 0402022165, 0402022169, 0402422003, 0402622007, 0402925148, 0403122053, 0403122057, 0403125009, 0403223079, 0403223083, 0403223087, 0403223091, 0403321066,0403321070, 0403423063, 0403423067, 0403423071, 0403423075, 0403423079, 0403423083, 0403423087, 0404022003, 0404622011, 0404622014, 0404622017, 0404622020, 0404622023, 0404822104, 0405025032, 0405924100, 0405924103, 0406624134, 0406624138, 0406624142, 0406722052, 0406722056, 0406722060, 0406722064, 0406823005, 0407625022, 0408025008, 0408222120, 0408222124, 0408222128, 0408222132, 0408922093, 0408922097, 0408922101, 0409622008, 0409822014, 0409822018, 0410822042, 0410822046, 0410823068, 0410923149, 0410923152, 0410923155, 0413223057, 0413223060, 0414223170, 0414223174, 0414223178, 0414223182, 0414223186, 0414223190, 0414223194, 0414223198, 0414323003, 0414323006, 0415223065, 0415223068, 0415223071, 0415223074, 0415923036, 0416924069, 0416924074, 0417422053, 0418023091, 0418023095, 0418023099, 0418023103, 0418023107, 0418023111, 0419223082, 0419523010, 0419724177, 0419924007, 0420223048, 0420223051, 0420223054, 0420223057, 0420223060, 0420823170, 0421322041, 0421322045, 0421623206, 0421623211, 0421623216, 0421623221, 0421623226, 0421623231, 0421623236, 0421623241, 0422923010, 0423023059, 0423023304, 0423023307, 0423023379, 0423023384, 0423023389, 0423023394, 0423023399, 0423023451, 0423422042, 0423422045, 0423422048, 0423924004, 0424224127, 0424224131, 0424323096, 0426223004, 0426223008, 0427922038, 0427922042, 0428824102, 0428924075, 0428924079, 0428924083, 0429823019, 0429823023, 0430323199, 0430523194, 0430523197, 0430722034, 0431123070, 0432324031, 0432324156, 0432324159, 0432324162, 0432324165, 0432722064, 0433724005, 0433724010, 0433724015, 0434023084, 0434023087, 0434023090, 0434023111, 0434023116, 0434023121, 0434622027, 0434622031, 0434622035, 0434722013, 0434722159, 0434722163, 0436223068, 0436624179, 0436624184, 0436624189, 0436624194;", "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\n440-392-7417", "reason_for_recall": "The DFPM yoke assembly (\"yoke assembly\") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.", "root_cause_description": "Process control", "action": "Steris issued an URGENT MEDICAL DEVICE RECALL NOTICE dated 06/17/2025 to its consignees on 06/23/2025 disseminated via FedEx. The notice explained the issue, potential risk, and requested the following: \nUser Action: Please ensure the following steps are completed:\n1. Review the revised Preventive Maintenance Manual and Interval Based Check List language depending on which HarmonyAIR Surgical Lighting System model(s) are in use at your facility (A-Series and/or E-Series) (please reference Attachments B-E of the letter for maintenance instructions).\n2. Immediately complete the maintenance activities as instructed, and then again annually going forward.\n3. Complete the Medical Device Recall Response Form included with this letter.\n4. Return the completed Response Form via email to: Regulatory_Compliance@STERIS.com, or via fax to 440-392-8963.\n5. Distributors: If you have further distributed this product, please identify your Customer(s), and notify them of this recall.", "product_quantity": "167 units", "distribution_pattern": "Worldwide - US Nationwide and Puerto Rico and the country of Canada.", "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" } } ] }