{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "86079", "product_res_number": "Z-0273-2010", "event_date_initiated": "2009-10-08", "event_date_posted": "2009-11-17", "recall_status": "Terminated", "event_date_terminated": "2012-04-02", "res_event_number": "53615", "product_code": "FCG", "k_numbers": [ "K934370" ], "product_description": "Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1610.\n\nBard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors", "code_info": "Lot Number: REQI0640 REQJ0110 REQK0190 REQK0376 REQK0818 REQL0207 RERA0671 RERB0028 RERB0580 RERC0286 RERD0535 RERE0157 RERE0679 RERE0825 RERG0081 RERH0338 RERH0484 RERH1054 RERI0145 RERI0583 RERJ0007 RERJ0564 RERK0165 RERK0261 RERK0706 RERL0186 RESA0227 RESA0230 RESA0822 RESB0375 RESB0978 RESC0424 RESD0095 RESD0591 RESE0372 RESF0027 RESF0558 RESF0725 RESG0412 RESH0055 RESH0717 RESI0709 RESK0646 Lot Number REQI0640 REQJ0110 REQK0190 REQK0376 REQK0818 REQL0207 RERA0671 RERB0028 RERB0580 RERC0286 RERD0535 RERE0157 RERE0679 RERE0825 RERG0081 RERH0338 RERH0484 RERH1054 RERI0145 RERI0583 RERJ0007 RERJ0564 RERK0165 RERK0261 RERK0706 RERL0186 RESA0227 RESA0230 RESA0822 RESB0375 RESB0978 RESC0424 RESD0095 RESD0591 RESE0372 RESF0027 RESF0558 RESF0725 RESG0412 RESH0055 RESH0717 RESI0709 RESK0646 and RETC0214", "firm_fei_number": "2020394", "recalling_firm": "Bard Peripheral Vascular Inc", "address_1": "1625 W 3rd St", "city": "Tempe", "state": "AZ", "postal_code": "85281-2438", "additional_info_contact": "480-894-9515", "reason_for_recall": "The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a loose hub connection. The exposed sample chamber will typically result in an inability to obtain the biopsy sample. In the majority of reported cases, there was no injury to the patient or user. When us", "root_cause_description": "Process design", "action": "The recall notification was initiated by the firm issuing an urgent medical device notification to it's consignees on October 08, 2009 via USPS requesting them to check all inventory locations for the affected products, remove and return affected products to Bard. The consignees were instructed to complete and return a recall effectiveness check form. Bard provided this 800 number 1-800-321-4254 for any questions consignees may have.", "product_quantity": "127,169 units", "distribution_pattern": "Nationwide and internationally to \nCanada\nMexico\nAlgeria \nAndorra \nAustria \nBahrain \nBelarus \nBelgium \nCroatia \nCyprus \nCzech Republic \nDenmark \nFinland \nFrance \nFrench Guiana \nGermany \nGibraltar \nGreece \nHungary \nIreland \nIsrael \nItaly \nIvory Coast \nKenya \nKuwait \nLatvia \nLebanon \nLuxembourg \nMalta \nMartinique \nMauritius \nMorocco \nNetherlands \nNew Caledonia \nNigeria \nNorway \nOman \nPoland \nPortugal \nRepublic of Kosovo \nRepublic of Macedonia \nReunion \nRomania \nRussia \nSaudi Arabia \nSenegal \nSerbia \nSeychelles \nSlovenia \nSouth Africa \nSpain \nSweden \nSwitzerland \nSyria \nTunisia \nTurkey \nUkraine \nUnited Arab Emirates \nUnited Kingdom \nAustralia\nNew Zealand\nCanada\nJapan\nBangladesh\nChina\nHong Kong\nIndia\nIndonesia\nKorea\nMalaysia\nPakistan\nSingapore\nSri Lanka\nTaiwan\nThailand\nVietnam\nArgentina\nBahamas\nBarbados\nBrazil\nChile\nColombia\nDominican Republic\nMexico\nPeru and\nSuriname", "openfda": { "k_number": [ "K840168", "K181756", "K013069", "K892068", "K951598", "K210476", "K896932", "K103668", "K021847", "K945813", "K961185", "K013070", "K252646", "K131925", "K140137", "K854289", "K062979", "K011075", "K212822", "K962569", "K934256", "K954596", "K915801", "K103694", "K890327", "K230909", "K070179", "K840144", "K212819", "K844993", "K050135", "K141894", "K800420", "K011270", "K073399", "K142688", "K051247", "K181994", "K840354", "K941722", "K924271", "K092359", "K160229", "K935844", "K070129", "K013356", "K171596", "K943304", "K151373", "K083330", "K133763", "K013071", "K160890", "K051506", "K910720", "K002946", "K902320", "K951421", "K024120", "K100712", "K093195", "K180363", "K012864", "K854404", "K013109", "K934356", "K981889", "K133008", "K962905", "K895897", "K983218", "K944944", "K002944", "K091257", "K902319", "K990220", "K971842", "K050503", "K945921", "K050120", "K963894", "K945133", "K021525", "K171956", "K180668", "K926559", "K945146", "K961897", "K231267", "K962570", "K231422", "K962568", "K250994", "K840157", "K151895", "K023272", "K882549", "K950810", "K936194", "K950982", "K800419", "K963565", "K180037", "K160423", "K040893", "K895725", "K800416", "K914732", "K191472", "K911397", "K960317", "K991672", "K934370", "K160098", "K954155", "K890203", "K771108", "K241209", "K970563", "K834249", "K891777", "K180449", "K954231", "K905556", "K002947", "K150891", "K081323", "K012358", "K212423", "K871467", "K083802", "K151738", "K941563" ], "registration_number": [ "3008044552", "", "8010312", "3005580113", "3001845648", "3005012805", "3010188783", "3030125051", "1000393132", "1319639", "3018094310", "2528981", "1721504", "3011088743", "3004784537", "9681260", "8010047", "2020394", "3012334073", "3042940295", "3007664053", "9615480", "3009337401", "3005216725", "3011642792", "3015924373", "3044026004", "1825146", "2518897", "3006082230", "1923569", "3030626857", "3010419931", "1721676", "3033589330", "3016844398", "1000121056", "3007748770", "3027641465", "9617616", "3004111573", "1423507", "1211566", "3009196578", "3004837686", "2134812", "9680269", "3015972753", "3015136750", "3029779285", "3006788678", "3013557562", "1220477", "1058584", "3015077548", "2124215", "2246552", "3010041511", "3012975098", "3002806603", "3010966701", "1625685", "1820334", "3015225571", "3007699067", "3030446844", "9680794", "2030624", "3012042439", "2183744", "9680904", "3004904811", "3004749705", "1048735", "3007544634", "1928237", "3011137372", "1061124", "3008040402", "3030447506", "3010515547", "3012536737", "3017210488", "1222140", "3009526575", "1417485", "3014769442", "1721686", "3011146996", "1221435", "2133772", "3006849754", "1528319", "3013462478", "3038356900", "3012494290", "1625425", "1047843", "2183456", "1225687", "1320894", "1000112137", "3014579161", "1724474", "3002807314", "9617592", "1828132", "3006950086", "3005099803", "3013440400", "3030733800", "9611481", "3014279513", "1835568", "3010273872", "3008773560", "1037905", "3012936513", "3043585886", "3004129994", "1018233", "3016678045", "3011050570", "9611612", "3015309643", "9614641", "9680809", "3003790304", "3000126629" ], "fei_number": [ "3008044552", "", "3002827704", "1000122656", "3005580113", "3001845648", "3005012805", "3010188783", "3030125051", "1000393132", "3018094310", "2528981", "3002807847", "1000080301", "1721504", "3011088743", "3004784537", "2020394", "3012334073", "3042940295", "3007664053", "3003094851", "3003793605", "3009337401", "3000126629", "3003705156", "3005216725", "1000138054", "3011642792", "3015924373", "3044026004", "1825146", "3006082230", "3007019930", "3000206435", "1923569", "3030626857", "3010419931", "1721676", "3033589330", "3016844398", "1000121056", "1000219637", "3007748770", "3027641465", "3004111573", "3008237808", "1211566", "3009196578", "3004837686", "3015972753", 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"3000209794", "3003790304", "3005747797" ], "device_name": "Biopsy Needle", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1075", "device_class": "2" } } ] }