{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "95835", "product_res_number": "Z-0812-2011", "event_date_initiated": "2010-10-20", "event_date_posted": "2010-12-27", "recall_status": "Terminated", "event_date_terminated": "2011-08-03", "res_event_number": "57317", "product_code": "FCG", "k_numbers": [ "K100712" ], "product_description": "Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 25GA (0.52 mm) sterile, UPN M00550021, 5 pack, 428 Technology Drive East, Menomonie, WI.\n\nDesigned to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.", "code_info": "Lot/Batch Number: 7442099.", "firm_fei_number": "3005099803", "recalling_firm": "Boston Scientific Corporation", "address_1": "100 Boston Scientific Way", "city": "Marlborough", "state": "MA", "postal_code": "01752-1234", "additional_info_contact": "Cindy Finney\n508-683-8000", "reason_for_recall": "The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.", "root_cause_description": "Other", "action": "\"Urgent Medical Device Recall - Immediate Action Required\" notification letters were sent via Federal Express Priority mail on October 20, 2010. The letters identified the affected product and stated the reason for the recall. The notification instructs the account to immediately discontinue use of, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory.", "product_quantity": "567 all products", "distribution_pattern": "Worldwide Distribution -- US and Canada.", "openfda": { "k_number": [ "K800419", "K962569", "K013069", "K945921", "K771108", "K051506", "K180449", "K954155", "K212423", "K962570", "K050135", "K902319", "K945133", "K950810", "K070129", "K840354", "K013071", "K924271", "K083802", "K895725", "K181756", "K252646", "K896932", "K140137", "K970563", "K180668", "K091257", "K050120", "K103668", "K023272", "K840157", "K854289", "K951598", "K002946", "K081323", "K902320", "K181994", "K070179", "K960317", "K934256", "K892068", "K092359", "K944944", "K971842", "K961897", "K934356", "K926559", "K840168", "K241209", "K890327", "K945146", "K943304", "K151738", "K151373", "K954231", "K160229", "K983218", "K840144", "K800416", "K013109", "K981889", "K935844", 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