{ "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": "74733", "product_res_number": "Z-0331-2009", "event_date_initiated": "2008-10-07", "event_date_posted": "2008-11-28", "recall_status": "Terminated", "event_date_terminated": "2011-12-10", "res_event_number": "50096", "product_code": "FCG", "k_numbers": [ "K040893" ], "product_description": "Boston Scientific Easy Core\" Biopsy System, 18 ga. x 15 cm, REF 43-453 , M001434531, Sterilized with ethylene oxide gas.\nUPN for inner pouch M001434530. \n\nIndicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.", "code_info": "11520532, 11539484, 11579252, and 11642796", "firm_fei_number": "3002095335", "recalling_firm": "Boston Scientific Corporation", "address_1": "1 Scimed Pl", "city": "Maple Grove", "state": "MN", "postal_code": "55311-1565", "additional_info_contact": "763-494-1700", "reason_for_recall": "Boston Scientific Corporation initiated a recall of its easy Core\" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device.", "root_cause_description": "Device Design", "action": "Consignees were sent a \"Boston Scientific Urgent Medical Device Recall\" letter dated October 21, 2008. The letter was addressed to The Hospital Field Action Contact. The letter described the problem and products being recalled. The letter stated that it was very important that the attached product table be used carefully and consider both inner and outer packaging product codes when searching for affected/recalled product as the UPN numbers on the inner and outer labeling are different. Requested to discontinue use of product, identify, and segregate and return affected products to BSC. Letter also requested to complete and return the Reply Verification Tracking Form.", "product_quantity": "3808 total for all products", "distribution_pattern": "Nationwide Distribution --- including states of AL, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT, NE , NV, NH, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and PR.", "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", 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