{ "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": "74707", "product_res_number": "Z-0495-2009", "event_date_initiated": "2008-10-17", "event_date_posted": "2009-01-12", "recall_status": "Terminated", "event_date_terminated": "2009-12-15", "res_event_number": "50087", "product_code": "FCG", "k_numbers": [ "K040893" ], "product_description": "Boston Scientific Easy Core Biopsy System, 18 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 1215, REF M00512150 and M00512151.\n\nFor use to endoscopically or percutaneously retrieve tissue samples 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": "Lot 0011537463.", "firm_fei_number": "1828132", "recalling_firm": "Boston Scientific Corp", "address_1": "780 Brookside Dr", "city": "Spencer", "state": "IN", "postal_code": "47460-1080", "additional_info_contact": "508-683-4678", "reason_for_recall": "These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.", "root_cause_description": "Nonconforming Material/Component", "action": "U.S. consignees were notified via letter dated 10/17/08, which informs them of the problem, instructs them to remove from use and quarantine the recalled lots and requests completion and submission of the Reply Verification Tracking form via fax at 508-683-5578. For questions about this recall, contact your local Boston Scientific representative.", "product_quantity": "430 of both systems.", "distribution_pattern": "Worldwide Distribution including USA and countries of Algeria, Austria, Australia, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Japan and United Arab Emirates.", "openfda": { "k_number": [ "K151895", "K231422", "K160423", "K962569", "K871467", "K941722", "K151373", "K092359", "K902320", "K180363", "K944944", "K012864", "K241209", "K934370", "K081323", "K013070", "K854289", "K951598", "K941563", "K181756", "K771108", "K013069", "K171956", "K962905", "K981889", "K971842", "K070129", "K834249", "K960317", "K141894", "K230909", "K954231", "K963894", "K040893", "K181994", "K050135", "K990220", "K051506", "K951421", "K840157", "K133763", "K160229", 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