{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219877", "product_res_number": "Z-2295-2026", "event_date_initiated": "2025-12-10", "event_date_posted": "2026-06-02", "recall_status": "Open, Classified", "res_event_number": "98817", "product_code": "FTC", "k_numbers": [ "K220840" ], "product_description": "Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4", "code_info": "Serial 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"firm_fei_number": "1526255", "recalling_firm": "Daavlin Distributing Company", "address_1": "205 W Bement St", "city": "Bryan", "state": "OH", "postal_code": "43506-1264", "additional_info_contact": "800-322-8546", "reason_for_recall": "Some of the Calibration/Output Certificates had the outputs reversed.", "root_cause_description": "Labeling Change Control", "action": "An URGENT: MEDICAL DEVICE ADVISORY NOTICE dated 12/11/25 was sent to customers.\n\nDual calibration allows you to treat at the surface (0 ) of the device or at 9 inches (9 ) away. It has come to our attention that some of the Calibration/Output Certificates had the outputs reversed.\n\nActions to be taken by the Customer/User:\nTalk to your physician regarding treatment plans with the new information listed below.\n\nIf you have any questions or concerns, please do not hesitate to contact our office at (800)\n322-8546. Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. Thank you for your\ncooperation.", "product_quantity": "368 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K812579", "K871237", "K924969", "K134009", "K103204", "K200971", "K852149", "K851533", "K861570", "K855162", "K810476", "K860859", "K872648", "K810688", "K890084", "K082731", "K031800", "K840931", "K833511", "K935840", "K861705", "K061589", "K840132", "K874889", "K223882", "K852053", "K850493", "K845029", "K834488", "K100378", "K933146", "K132643", "K872707", "K853177", "K861447", "K843306", "K011197", "K904427", "K853394", "K843647", "K840137", "K860489", "K853833", "K244022", "K810796", "K852957", "K922963", "K811586", "K833490", "K913760", "K153749", "K852579", "K811870", "K833240", "K904428", "K072035", "K872649", "K860509", "K853752", "K852576", "K861533", "K924077", "K860347", "K864485", "K040062", "K863518", "K192411", "K841614", "K854170", "K900649", "K872706", "K761189", "K800950", "K904425", "K862372", "K934808", "K933953", "K935524", "K191086", "K900693", "K242977", "K882722", "K854707", "K854171", "K173436", "K050695", "K860929", "K860931", "K834493", "K812446", "K761187", "K130519", "K820123", "K021514", "K895410", "K220840", "K851858", "K171702", "K111172", "K851536", "K851535", "K854515", "K761179", "K792500", "K840133", "K192642", "K813307", "K022165", "K851408", "K103540", "K063621", "K812521", "K854111", "K091568", "K834491", "K881385", "K843902", "K854004", "K883929", "K151795", "K872651", "K851534", "K935526", "K803264", "K843814", "K853046", "K041212", "K861076", "K073066", "K110912", "K103708", "K820492", "K853679", "K861989", "K770862", "K760482", "K800160", "K861963", "K870167", "K242908", "K854750", "K930856", "K850205", "K833350", "K933952", "K885029", "K761186", "K833524", "K915426", "K862263", "K833527", "K170489", "K853545", "K073503", "K982082", "K230382", "K024020", "K253871", "K853692", "K854131", "K021092", "K801017", "K851532", "K811585", "K933954", "K042502", "K860930", "K832794", "K925171", "K885026", "K202827", "K851859", "K852684", "K073587", "K850204", "K896191", "K842575", "K834492", "K873430", "K254234", "K863937", "K935572", "K883952", "K210004", "K230076", "K842384", "K790167", "K052660", "K050080", "K233811", "K842975", "K862142", "K885025", "K872604", "K761188", "K210881", "K850042", "K020591", "K051330", "K812663", "K760471", "K844039", "K862608", "K864907", "K885184", "K061295", "K840158", "K850660", "K854932", "K845028", "K862341", "K090097", "K250425", "K872605", "K070934", "K854594", "K150752", "K812543", "K852534", "K172273", "K852348", "K850206", "K853587", "K862097", "K852243", "K910767", "K111049", "K021762", "K854154", "K860198", "K861107", "K854224", "K851255", "K845001", "K854020", "K182215", "K022104", "K860117", "K827890", "K881923", "K864510", "K860566", "K863555", "K853911", "K853846", "K864546", "K834495", "K842787", "K812225", "K811029", "K853248", "K033946", "K150912", "K850203", "K852290", "K844870", "K860144", "K860567", "K901324", "K872650", "K935525", "K861636", "K212510", "K864511", "K860370", "K896831", "K181805", "K854498", "K860856", "K860932", "K904426", "K191571" ], "registration_number": [ "3015060197", "9680413", "3008872264", "3036425107", "1528161", "3008393409", "1318319", "3005205318", "3006580954", "1526255", "3023306694", "3009736547", "3017406171", "3014226003", "3004193926", "3011024620", "3002672225", "3004374705", "3004167969", "3007699081", "3016746323", "3013229265", "3003882673", "3008255748", "1022129", "3045522560" ], "fei_number": [ "3015060197", "3008872264", "3036425107", "3004531930", "3008393409", "1318319", "3005205318", "3006580954", "1526255", "3023306694", "3009736547", "3017406171", "3014226003", "3004193926", "3011024620", "3002672225", "3004374705", "3004167969", "3007699081", "1000122747", "3016746323", "3013229265", "3003882673", "3008255748", "1022129", "3045522560" ], "device_name": "Light, Ultraviolet, Dermatological", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4630", "device_class": "2" } } ] }