{ "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": 12 } }, "results": [ { "cfres_id": "180316", "product_res_number": "Z-1729-2020", "event_date_initiated": "2020-03-09", "event_date_posted": "2020-04-01", "recall_status": "Open, Classified", "res_event_number": "85227", "product_code": "EZB", "product_description": "Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM\nUPN: M0066703051 box 5 \nUPN: M0066703050 single unit", "code_info": "Lot Numbers: 24423656, 24423820, 24424087, 24427952, 24427959, 24428330, 24430010, 24437882, 24440182, 24440998, 24444952, 24446611, 24447516, 24447658, 24447722, 24447735, 24451828, 24452126, 24452132, 24452266, 24454238, 24455297, 24455381, 24455732, 24460452, 24460458, 24466032, 24487805, 24493956, 24494611, 24498583, 24498730, 24498732, 24499924, 24501439, 24506583, 24563429, 24563891, 24564727, 24564729, 24569684, 24570465, 24571203, 24579763, 24599358, 24609013, 24609991, 24614307, 24615296, 24620493, 24621357, 24621789, 24622541, 24623111, 24623117, 24623321, 24623461, 24623472, 24640257, 24661651, 24662199, 24663152, 24663562, 24663570, 24665001, 24665005, 24665100, 24665108, 24665990, 24666401, 24670677, 24672232, 24672553, 24678045, 24678047, 24681044, 24699798, 24700605, 24702016, 24708365, 24708371, 24709540, 24709550, 24710261, 24716280, 24716623, 24719303, 24723783, 24724284, 24732445, 24732731, 24738283, 24751717, 24756104, 24758578, 24763250, 24765356, 24766287, 24766401, 24772737, 24773528", "firm_fei_number": "3005099803", "recalling_firm": "Boston Scientific", "address_1": "100 Boston Scientific Way", "city": "Marlborough", "state": "MA", "postal_code": "01752-1234", "additional_info_contact": "Nicole Pshon\n763-494-1133", "reason_for_recall": "An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a\nprocedural delay due to the need to exchange the affected device", "root_cause_description": "Component change control", "action": "Boston Scientific issued Customer Notification on March 9, 2020 stating reason for recall, health risk and action to take: cease distribution or use of any remaining product affected by this removal should cease immediately; Verify by product lot/batch number in the product table whether any product within your inventory is affected. If so, indicate on your Verification Form the quantity of units from each lot/batch that you will bereturning. As some of these products within these lots/batches are sold as 5-packs, it is important that all\nreported quantities represent the actual number of single units being returned and not the number of cartons/boxes or multi-packs; If you identify any product from the affected lots/batches within your inventory, please segregate the\nproduct immediately and return it to BSC in accordance with the enclosed instructions. If you are a distributor, please note that the depth is to the hospital level and this notification should be forwarded to your customers. If you are a facility that has sent products to another hospital within your network, please ensure that this notification is forwarded to them.", "product_quantity": "25,956", "distribution_pattern": "Nationwide\nForeign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan", "openfda": { "device_name": "Stylet For Catheter, Gastro-Urology", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5130", "device_class": "1", "k_number": [ "K971498", "K874164", "K970994" ], "registration_number": [ "9681477", "9617744", "3005987240", "2521453", "3011137372", "3004134316", "1820334", "9616246", "3014334038", "3008988055", "3010155661", "9611610", "3003418325", "1923569", "3010273872", "1651252", "3009051888", "3004579081", "3005809810", "3013666336", "9681260", "9616067", "3004215117", "2183744", "2126666", "2124215", "3002807314", "1825146", "3012267976", "3017210488", "3007695959", "9611590", "3004859241", "1313046", "3005099803", "8030607", "1000121056", "3006082230", "1836161", "1018233", "3010041511", "3001644167", "3004365956", "2027111", "9613079", "3009763019", "8040278", "3004608878" ], "fei_number": [ "3005987240", "2521453", "3006509795", "3004134316", "3005747797", "3002750084", "1820334", "3014334038", "3008988055", "3010155661", "3003418325", "3006279007", "1923569", "3010273872", "1000237915", "3009051888", "3004579081", "3005809810", "3013666336", "3004215117", "2183744", "2126666", "2124215", "3002807314", "3004216008", "1825146", "3012267976", "3017210488", "3007695959", "3002770040", "3004859241", "3002807439", "1313046", "3002807214", "3005099803", "3002806565", "1000121056", "3006082230", "3001644167", "1018233", "3010041511", "3004365956", "2027111", "3001436772", "3009763019", "3003052153", "3004608878", "3002807264" ] } } ] }