{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "86080", "product_res_number": "Z-0274-2010", "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: MN1613.\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: REQI0632 REQJ0353 REQK0281 REQK0377 RERA0355 RERB0142 RERC0031 RERD0071 RERD0117 RERE0156 RERE0547 RERG0317 RERH0719 RERI0584 RERK0426 RERL0187 RESA0699 RESB0560 RESC0584 RESD0592 RESE0373 RESF0560 RESG0181 RESH0718 RESI0438 RESJ0549 RESJ0550 RETB0903 and RETB0904", "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": "32, 427 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": [ "K100712", "K013069", "K181994", "K961185", "K160098", "K070129", "K023272", "K840354", "K103694", "K800416", "K941722", "K954596", "K945146", "K891777", "K944944", "K936194", "K180449", "K840157", "K882549", "K961897", "K133008", "K981889", "K971842", "K962568", "K911397", "K892068", "K011270", "K231267", "K943304", "K871467", "K040893", "K002944", "K051506", "K160890", "K024120", "K941563", "K062979", "K140137", "K050503", "K210476", "K771108", "K962905", "K840144", "K171956", "K954231", "K902319", "K950982", "K890203", "K212819", "K926559", "K915801", "K013070", "K180037", "K945921", "K962570", "K895897", "K834249", "K983218", "K013356", "K840168", "K963894", "K954155", "K091257", "K945133", "K151373", "K051247", "K212822", "K103668", "K013071", "K160229", "K151895", "K002946", "K990220", "K895725", "K934370", "K914732", 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"3015972753", "3003793605", "1820334", "3000206435" ], "device_name": "Biopsy Needle", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1075", "device_class": "2" } } ] }