{ "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": 3 } }, "results": [ { "cfres_id": "219876", "product_res_number": "Z-2322-2026", "event_date_initiated": "2026-04-30", "event_date_posted": "2026-06-05", "recall_status": "Open, Classified", "res_event_number": "98814", "product_code": "HQE", "k_numbers": [ "K213467" ], "product_description": "TDC VELOCE\", 23G Two Dimensional Cutter - 20k CPM;\nArticle Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201, 9311.23G01-00;", "code_info": "1. Article Number: 9268.VIT23; UDI-DI: 08717872031866; \n2. Article Number: 9311.23G01; UDI-DI: 08717872035109;\n3. Article Number: 9311.23G02; UDI-DI: 08717872035338;\n4. Article Number: 9311.23K01; UDI-DI: N/A; \n5. Article Number: 9311.23K02; UDI-DI: N/A;\n6. Article Number: 9311.23K03; UDI-DI: N/A;\n7. Article Number: 9623.G0201; UDI-DI: N/A;\n8. Article Number: 9623.G0202; UDI-DI: N/A;\n9. Article Number: 9623.K0201; UDI-DI: N/A;\n10. Article Number: 9311.23G01-00; UDI-DI: 08717872035307;\n\nLot Numbers: 100637001, 57682-*-*-1, 64312-*-*-1, 69017-*-*-1, 73237-*-*-1, 74225-*-*-1, 75735-*-*-1, 79460-*-*-1, 80338-*-*-1, 80963-*-*-1, 81335-*-*-1, 81679-*-*-1, 82213-*-*-1, 82325-*-*-1, 82742-*-*-1, 82779-*-*-1, 83584-*-*-1, 84580-*-*-1, 85451001, 86069001, 86798001, 86799001, 87205001, 88231001, 91957001, 92629001, 92630001, 93336001, 94351001, 95436001, 95462001, 96097001, 96123001, 97279001, 97789001, 98643001, 99130001, 99185001, 99697001;", "firm_fei_number": "3002806863", "recalling_firm": "D.O.R.C. Dutch Opthalmic Research Center Intl B.V.", "address_1": "Scheijdelveweg 2 2 scheijdelveweg", "city": "Zuidland", "country": "Netherlands", "additional_info_contact": "IQVIA MedTech\n1-585-471 6812", "reason_for_recall": "An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.", "root_cause_description": "Process design", "action": "On April 30, 2026 Urgent Medical Device Recall letters were sent to customers. Actions to be taken: \nReview this Product information as soon as possible with relevant members of your staff.\n1. Pass this FSN as soon as possible on to all those who need to be aware of it, including other locations, organizations and/or customers who might have received the impacted Product(s) through you.\n2. If you have the affected Products and the affected lots (see attachment below) in your\ninventory, remove and return them to DORC following the instructions in the attachment.\n3. Follow the instructions on how to complete and submit the Field Action Acknowledgement Form that is provided with this FSN.", "product_quantity": "314 boxes, totaling 1884 units", "distribution_pattern": "Worldwide - US Nationwide and the countries of AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CZECHIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, IRELAND, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, TURKEY.", "openfda": { "k_number": [ "K853308", "K850857", "K970673", "K885196", "K894278", "K862943", "K862188", "K842471", "K834155", "K946181", "K936302", "K880968", "K834160", "K940391", "K834163", "K910973", "K912253", "K771711", "K800110", "K834162", "K904909", "K853430", "K844510", "K913837", "K141065", "K940746", "K992943", "K833371", "K832446", "K924353", "K010082", "K883975", "K924222", "K881927", "K883926", "K890622", "K890300", "K834437", "K933208", "K861565", "K033390", "K864035", "K854871", "K844715", "K920582", "K980488", "K212763", "K884043", "K883605", "K843391", "K946135", "K791212", "K170183", "K853382", "K924604", "K950799", "K853961", "K120170", "K913261", "K813389", "K953575", "K890544", "K970670", "K890133", "K852271", "K933907", "K851610", "K820933", "K842188", "K832235", "K920718", "K020911", "K896305", "K813500", "K980400", "K934204", "K913504", "K871375", "K023939", "K853457", "K862343", "K851936", "K861380", "K921460", "K960061", "K914038", "K854868", "K954816", "K121675", "K884557", "K853135", "K843594", "K884556", "K831584", "K820026", "K842197", "K911998", "K921758", "K894248", "K964743", "K896943", "K950852", "K860014", "K930842", "K801850", "K895813", "K933984", "K854508", "K841738", "K914221", "K842793", "K990292", "K932668", "K932669", "K912384", "K870775", "K812857", "K860891", "K961738", "K813274", "K961078", "K934600", "K983797", "K851272", "K980399", "K830216", "K844374", "K915745", "K871871", "K781471", "K843041", "K872312", "K822220", "K870068", "K896754", "K830037", "K953576", "K891601", "K881520", "K102222", "K153168", "K820008", "K030948", "K880929", "K881519", "K922355", "K880943", "K890195", "K832703" ], "registration_number": [ "8030967", "3010291427", "2953359", "2028159", "3015456951", "1047843", "2529392", "3019924", "3042928348", "1722139", "2246552", "1644019", "1932180", "3005012805", "1932402", "3009337401", "1650907", "3015276088", "3045817901", "3010208880", "3003398873", "3002907620", "3009039068", "9615010", "1526711", "2523835", "9681121", "3010220595", "3007648309", "9611516", "1313525", "2028523", "2935428", "3006946276", "1928237", "3005941719", "1920664", "3002807090" ], "fei_number": [ "3010291427", "3015456951", "1047843", "1000117172", "3019924", "3002807944", "3042928348", "3006003617", "2246552", "3005012805", "1317628", "1000117501", "1000221463", "3002806863", "3009337401", "3015276088", "3045817901", "3010208880", "1000125771", "3003398873", "3002907620", "3003481798", "3009039068", "1000119305", "1526711", "1000125147", "3002681132", "1000640985", "1000121498", "2523835", "3010220595", "3007648309", "1000119053", "3006946276", "1928237", "3002807111", "1920664", "3000215205" ], "device_name": "Instrument, Vitreous Aspiration And Cutting, Ac-Powered", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.4150", "device_class": "2" } } ] }