{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "142118", "product_res_number": "Z-0820-2016", "event_date_initiated": "2015-12-02", "event_date_posted": "2016-02-18", "recall_status": "Terminated", "event_date_terminated": "2019-07-18", "res_event_number": "72749", "product_code": "GDW", "k_numbers": [ "K111825" ], "product_description": "Covidien Endo GIA Ultra Universal Standard Stapler Handle\nRef: EGIAUSTND\n\nProduct Usage:\nThe Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.", "code_info": "RANGES OF LOT NUMBERS (all lot numbers within each range are affected) Lot # starting with P3C through P5B0521X P5D0410X through P5D0411X P5D0823X through P5D0829X  P5E0080X through P5E0082X  P5E0317X through P5E0320X  P5E0322X through P5E0324X  P5F0001X through P5F0002X  INDIVIDUAL LOT NUMBERS (in addition to ranges) P5C0239X, P5C0241X, P5C0508X, P5C0510X, P5C0512X, P5C0597X P5C0599X, P5C0601X, P5C0603X, P5C0684X, P5C0803X, P5C0805X, P5C0807X. P5E0527X, P5E0529X   P5D0067X, P5D0069X , P5D0073X, P5D0170X, P5D0413X, P5D0415X ,P5D0417X, P5D0419X, P5D0447X, P5D0623X, P5D0624X ,P5D0626X, P5D0628X\t  P5D0630X, P5E0525X, P5F0004X, P5F0006X, P5F0008X, P5F0010X, P5F0014X, P5F0017X, P5F0019X, P5F0021X, P5F0213X, P5F0217X", "firm_fei_number": "1219930", "recalling_firm": "Medtronic", "address_1": "60 Middletown Ave", "city": "North Haven", "state": "CT", "postal_code": "06473-3908", "reason_for_recall": "Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use", "root_cause_description": "Process control", "action": "Medtronic sent an Urgent Medical Device Recall letters dated December 2 2015 and an Updated Urgent Medical Device Recall letter dated January 13, 2016, to affected customers, via Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473.\nFor questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at (800) 882-5878.", "product_quantity": "1,102,166 units", "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of \nCanada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.", "openfda": { "k_number": [ "K980617", "K983536", "K913411", "K181657", "K190884", "K123318", "K123718", "K063075", "K241630", "K963015", "K843603", "K111111", "K203117", "K915693", "K061156", "K021701", "K991030", "K120373", "K033602", "K122781", "K172561", "K071023", "K163698", "K062850", "K142808", "K060494", "K042492", "K191287", "K071708", "K163454", "K983318", "K131303", "K024117", "K202467", "K092577", "K221005", "K110049", "K140118", "K780586", "K162710", "K102632", "K020343", "K051301", "K210278", "K023725", "K063746", "K150026", "K053631", "K140609", "K222487", "K873748", "K913211", "K102325", "K103470", "K131563", "K222210", "K172960", "K250835", "K073148", "K013860", "K091215", "K885222", "K040720", "K131637", "K900043", "K032973", 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"K182217", "K171589", "K162947", "K892233", "K024275", "K913139", "K201882", "K821994", "K260196", "K032347", "K083527", "K131663", "K133938", "K091322", "K071920", "K092483", "K140560", "K761064", "K180175", "K151081", "K100386", "K160521", "K093410", "K913832", "K191070", "K041331", "K071061", "K211811", "K190331", "K091900", "K210909", "K970817", "K931103", "K801154", "K130653", "K890841", "K022313", "K931056", "K121474", "K132472", "K160900", "K020779", "K173443", "K881484", "K221771", "K080839", "K090821", "K202507", "K822345", "K950006", "K073001", "K132669", "K110728", "K013749", "K003169", "K001895", "K111064", "K151659", "K221013", "K200320", "K202709", "K202864", "K133762", "K160969", "K200420", "K040038", "K080898", "K062869", "K192566", "K211458", "K942606", "K093253", "K201639", "K161137", "K222641", "K093845", "K162252", "K183435", "K012362", "K920752", "K914130", "K900055", "K132698", "K140170", "K052910", "K103263", "K211197", "K014286", "K910192", "K131511", "K160176", 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