{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "182412", "product_res_number": "Z-2768-2020", "event_date_initiated": "2020-06-26", "event_date_posted": "2020-08-05", "recall_status": "Open, Classified", "res_event_number": "86001", "product_code": "FCG", "k_numbers": [ "K180037" ], "product_description": "Beacon EUS Access System Preloaded Access 90degree Needle\nsterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.", "code_info": "Model # DSA-090-01 UDI: 10884521722583 Lot #: F2510370X, F2510900X, F2512340X, F2512378X, F2512492X, F2512620X, F2513452X", "firm_fei_number": "1282497", "recalling_firm": "Covidien Llc", "address_1": "15 Hampshire St", "city": "Mansfield", "state": "MA", "postal_code": "02048-1113", "additional_info_contact": "770-662-0510", "reason_for_recall": "This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.", "root_cause_description": "Under Investigation by firm", "action": "Medtronic sent a letter notification to customers dated July 06, 2020 recalling effected lots of product. This letter instructed customers to discontinue use of the product and quarantine effected inventory. Customers were also instructed to return effected product and complete recall response forms accordingly.", "product_quantity": "375 units", "distribution_pattern": "world wide distribution", "openfda": { "k_number": [ "K962570", "K011270", "K840144", "K002944", "K962568", "K212423", "K131925", "K891777", "K160098", "K092359", "K800420", "K012864", "K093195", "K800416", "K100712", "K895897", "K983218", "K840354", "K991672", "K800419", "K151895", "K160890", "K945133", "K834249", "K902319", "K021847", "K926559", "K945921", "K954596", "K171956", "K950810", "K840168", "K951421", "K905556", "K083330", "K051506", "K133008", "K171596", "K023272", "K011075", "K915801", "K151373", "K180363", "K212822", "K081323", "K180449", "K050135", "K212819", "K012358", "K890203", "K954231", "K140137", "K962569", "K934356", "K945146", "K935844", "K844993", "K854404", "K160229", "K902320", "K911397", "K950982", "K002946", "K840157", "K910720", "K882549", "K871467", "K892068", "K963565", "K230909", "K970563", 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