{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "52170", "product_res_number": "Z-0830-2007", "event_date_initiated": "2007-05-04", "event_date_posted": "2007-05-24", "recall_status": "Terminated", "event_date_terminated": "2008-09-24", "res_event_number": "37903", "product_code": "DTZ", "product_description": "Endura No-React Dural Substitute 6 cm x 10 cm", "code_info": "Product code: ENR20610; all lots", "firm_fei_number": "3003418325", "recalling_firm": "Integra LifeSciences Corp.", "address_1": "311 Enterprise Dr", "city": "Plainsboro", "state": "NJ", "postal_code": "08536-3344", "additional_info_contact": "Judith E. O'Grady\n609-936-2311", "reason_for_recall": "Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall letter to Shelhigh citing sterility and other manufacturing concerns regarding this product manufactured by Shelhigh. Integra is a distributor of t", "root_cause_description": "Other", "action": "On May 4, 2007, an Urgent Recall Notice and accompanying recall acknowledgement form was sent to all customers that had purchased or been supplied EnDura No-React Dural Substitute product since sale of the product was initiated in 2003. Recall Coordinators at each facility are asked to review inventory for EnDura products and to call Integra Customer Service for an authorization number for return of product.", "product_quantity": "12,736 for all recalls Z-0827-0832-2007", "distribution_pattern": "Nationwide Distribution to hospitals and medical centers", "openfda": { "k_number": [ "K831122", "K242503", "K990103", "K861641", "K894970", "K223161", "K910107", "K241352", "K912655", "K790356", "K022115", "K140177", "K961530", "K863249", "K872133", "K802328", "K810470", "K811004", "K843955", "K772237", "K102464", "K974085", "K862918", "K191444", "K802719", "K202510", "K103191", "K925626", "K823125", "K802720", "K231414", "K901253", "K050447", "K061628", "K891230", "K932252", "K843956", "K133261", "K810532", "K200683", "K212341", "K964043", "K893704", "K183490", "K872107", "K897068", "K923272", "K833518", "K090450", "K844901", "K882892", "K071494", "K873923", "K772284", "K823273", "K821216", "K841476", "K202206", "K964967", "K092895", "K162016", "K970463", "K810505", "K240934", "K010443", "K172984", "K851035", "K961000", "K122844", "K203111", "K812660", "K073380", "K831894", "K892664", "K030264", "K864235", "K153140", "K962667", "K853251", "K850630", "K222297", "K004001", "K963518", "K191246", "K890808", "K072091", "K803231", "K971877", "K143073", "K991452", "K842908", "K861177", "K101153", "K230640", "K201916", "K853080", "K951247", "K823343", "K760824", "K013480", "K201642", "K901624", "K112360", "K892641", "K926467", "K984271", "K121909", "K033323", "K051997", "K922933", "K781223", "K132829", "K072362", "K013038", "K191029", "K151389", "K874841", "K880021", "K833670", "K153213", "K013915", "K860539", "K231982", "K974812", "K891687", "K140181", "K150489", "K162896", "K962641", "K180950", "K896978", "K040210", "K043323", "K941653", "K151791", "K071774", "K180448", "K903436", "K883054", "K000255", "K933586", "K061031", "K973760", "K893207", "K901250", "K922799", "K093522", "K831895", "K953835", "K130359", "K001021", "K953976", "K912078", "K022450", "K911227", "K153295", "K250821", "K203424", "K800555", "K253838", "K895393", "K960074", "K200109", "K954850", "K031903", "K150267", "K830639", "K100278", "K926226", "K151713", "K102109", "K122827", "K860673", "K140774", "K231652", "K142784", "K240666", "K130520", "K895632", "K992559", "K130280", "K113626", "K896671", "K130209", "K172071", "K083021", "K121536", "K020351", "K062381", "K020997", "K912079", "K010478", "K992910", "K912920", "K823456", "K090511", "K802970", "K090449", "K790406", "K920889", "K912082", "K031223", "K172626", "K894103", "K231773", "K781842", "K190690", "K980974", "K831705", "K090689", "K854045", "K894630", "K830327", "K000430", "K120185", "K863476", "K961734", "K833078", "K183511", "K082117", "K813255", "K014080", "K894826", "K780078", "K803003", "K211495", "K130493", "K925076", "K082403", "K822803", "K934292", "K821477", "K863515", "K991737", "K071572", "K883053", "K141492", "K792039", "K130433", "K901249", "K931444", "K925075", "K941225", "K130333", "K122254", "K080708", "K833253", "K941473", "K121229", "K023381", "K100645", "K123314", "K801240", "K993772" ], "registration_number": [ "9680841", "3015136750", "2011171", "3019807891", "3010155661", "3014990448", "3010163695", "3009507273", "1625519", "1643817", "9617601", "3030125051", "3011554160", "2916596", "1928237", "8010026", "3013267343", "2184009", "1319639", "9681834", "3002807090", "1220648", "3008307705", "3003752502", "3002806603", "1218444", "8010762", "2528981", "3016746283", "3021599320", "3045892899", "1124841", "3005941719", "3044156918" ], "fei_number": [ "1000116158", "1000138054", "3015136750", "2011171", "3019807891", "3010155661", "3014990448", "3000204839", "3010163695", "3009507273", "1625519", "1643817", "3030125051", "3002534070", "2828", "3011554160", "3005426550", "2916596", "1928237", "3013267343", "3009649876", "3002808327", "1220648", "3006003617", "3008307705", "3003752502", "3002806603", "1218444", "2528981", "3016746283", "3021599320", "3045892899", "3002807111", "3044156918" ], "device_name": "Oxygenator, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4350", "device_class": "2" } } ] }