{ "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": "2026-09-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222393", "product_res_number": "Z-3258-2026", "event_date_initiated": "2026-08-12", "event_date_posted": "2026-09-23", "recall_status": "Open, Classified", "res_event_number": "99745", "product_code": "DSY", "k_numbers": [ "K103347" ], "product_description": "Cardioroot Woven Collagen Coated Vascular Graft;\r\nModel Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;", "code_info": "1. Model Number: HEWROOT0024;\nUDI-DI: 00384401013884;\nSerial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life;\n\n2. Model Number: HEWROOT0026; \nUDI-DI: 00384401013891;\nSerial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life;\n\n3. Model Number: HEWROOT0028; \nUDI-DI: 00384401013907;\nSerial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life;\n\n4. Model Number: HEWROOT0030; \nUDI-DI: 00384401013914;\nSerial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life;\n\n5. Model Number: HEWROOT0032;\nUDI-DI: 00384401013921;\nSerial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life;\n\n6. Model Number: HEWROOT0034;\nUDI-DI: 00384401013938;\nSerial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life;", "firm_fei_number": "3002707083", "recalling_firm": "INTERVASCULAR, SAS", "address_1": "1 Zone Industrielle Athelia", "city": "La Ciotat Cedex", "country": "France", "reason_for_recall": "Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).", "root_cause_description": "Under Investigation by firm", "action": "On August 12, 2026 URGENT MEDICAL DEVICE RECALL letters were sent to customers.\nActions to be taken:\n1. Ensure all affected product in your inventory has been properly quarantined.\n2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred.\n3. Always report any adverse events potentially related to the affected products to your Getinge representative.", "product_quantity": "16329 (3880 US, 12449 OUS)", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jordan, Kenya, Kosovo, Kuwait, Latvia, Luxembourg, Malaysia, Mauritius, Monaco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom, Yemen.", "openfda": { "k_number": [ "K013250", "K060741", "K884083", "K964625", "K141124", "K901641", "K831822", "K091778", "K964197", "K102596", "K904282", "K882314", "K960706", "K013651", "K910865", "K010516", "K021547", "K991602", "K202471", "K811441", "K221628", "K013577", "K760090", "K991027", "K944858", "K062161", "K962433", "K770236", "K241070", "K922025", "K910863", "K830016", "K052282", "K093817", "K963790", "K862739", "K162803", "K830543", "K983861", "K103347", "K914447", "K990503", "K901682", "K955532", "K954582", "K022242", "K812248", "K882289", "K240083", "K071778", "K802095", "K854431", "K020767", "K970843", "K961134", "K964665", "K811510", "K955230", "K990800", "K853101", "K760092", "K820696", "K010517", "K202703", "K252445", "K940816", "K910864", "K820600", "K012952", "K913143", "K854845", "K183613", "K060142", "K903964", "K821158", "K771819", "K130142", "K801156", "K832806", "K233551", "K983819", "K162794", "K142062", "K893459", "K060124", "K890597", "K961847", "K040829", "K896964", "K052964", "K051332", "K043552", "K092863", "K992960", "K983064", "K922905", "K050049", "K180957", "K894732", "K870884", "K914116", "K002007", "K252277", "K964959", "K203724", "K034010", "K051312", "K933590", "K955588", "K992832", "K841596", "K172637", "K831865", "K760091", "K041528", "K903931", "K984182", "K094044", "K810845", "K881283", "K910866", "K853725", "K130016", "K991813", "K962639", "K833716", "K091491", "K032900", "K232312", "K083169", "K001927", "K905067", "K124039", "K941981", "K912911", "K905269", "K831880", "K213845", "K061626", "K971192", "K880040", "K993667", "K233783", "K880041", "K821716", "K241550", "K880167", "K013022", "K093934", "K231505", "K153523", "K800149", "K000499", "K121532", "K004011", "K933987", "K770235", "K113101", "K981079", "K791828", "K810376", "K925123", "K933204", "K090987", "K861808", "K955460", "K890182", "K822633", "K871110", "K953288", "K801621", "K933943", "K905270", "K120006", "K862697", "K131778", "K984294", "K940062", "K150389", "K952293", "K760130", "K803000", "K071923", "K122138", "K130215", "K030999", "K231972", "K992443" ], "pma_number": [ "P840029" ], "registration_number": [ "1721504", "1720929", "2020394", "1724474", "2017233", "3007676031", "1220477", "3008307705", "3010407203", "3010097171", "1018233", "3015225571", "1220948", "3010162973", "2246552", "1721676", "3006950086", "2242352", "9612515", "3006082230", "1723241", "3012536737", "3011175548", "3045042524", "3013718163", "3015309643", "3033589330", "1640201" ], "fei_number": [ "1721504", "1720929", "2020394", "3002807041", "3007676031", "2017233", "1220477", "3008307705", "3010407203", "3010097171", "1000517719", "1018233", "3002808437", "3015225571", "1220948", "2246552", "1721676", "3006950086", "2242352", "3006082230", "3012536737", "3003094851", "3011175548", "3045042524", "3013718163", "3015309643", "3002707083", "3033589330" ], "device_name": "Prosthesis, Vascular Graft, Of 6mm And Greater Diameter", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3450", "device_class": "2" } } ] }