{ "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": 21 } }, "results": [ { "cfres_id": "103742", "product_res_number": "Z-0029-2012", "event_date_initiated": "2011-08-25", "event_date_posted": "2011-10-07", "recall_status": "Terminated", "event_date_terminated": "2012-09-28", "res_event_number": "59787", "product_code": "FCG", "k_numbers": [ "K050503" ], "product_description": "OLYMPUS ViziShot EBUS Aspiration Needle\n\nEndobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.", "code_info": "Models: NA-201SX-4022-A --22 gauge needle: all lot numbers; NA-201SX-4022-B --22 gauge needle: all lot numbers; NA-201SX-4022-C --22 gauge needle: all lot numbers; and NA-201SX-4021 -- 21 gauge needle: all lot numbers.", "firm_fei_number": "2429304", "recalling_firm": "Olympus America Inc.", "address_1": "3500 Corporate Pkwy.", "address_2": "P.O. Box 610", "city": "Center Valley", "state": "PA", "postal_code": "18034-0610", "additional_info_contact": "Laura Storms-Tyler\n484-896-5688", "reason_for_recall": "Firm has received complaints from users of the ability to wipe material from the needle's stylet and the presence of material in patient cytology samples obtained by the needle following endobronchial ultrasound fine needle aspiration of a lesion. Olympus Medical Systems Corporation (OMSC) in Japan has confirmed that metal particles can occur on the stylet due to friction between the stylet and n", "root_cause_description": "Device Design", "action": "OLYMPUS sent an URGENT MEDICAL DEVICE CORRECTION letter dated August 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A revised Instruction Manual with the new WARNINGS will be sent to the customer's attention.\n\nCustomers were instructed to examine their inventory to determine if they have the affected product.\nTo share the information on the new WARNINGS with all of the appropriate staff at their facility and any other organization where the product has been transferred.\nComplete and return the enclosed questionnaire even if they do not have affected product. \nCustomers were instructed to fax the completed questionnaire to 484-896-7128.\n\nFor any question call 484-896-5688.", "product_quantity": "22,498", "distribution_pattern": "Nationwide Distribution including the District of Columbia and the following States: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.", "openfda": { "k_number": [ "K100712", "K013069", "K181994", "K961185", "K160098", 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}