{ "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": "36664", "product_res_number": "Z-0555-05", "event_date_initiated": "2004-11-18", "event_date_posted": "2005-02-18", "recall_status": "Terminated", "event_date_terminated": "2008-11-19", "res_event_number": "30826", "product_code": "NIQ", "product_description": "Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System CXSxxxxx", "code_info": "Lot # 50704127, 50804011, 40804419, 40804422, 40804454, 40904372, 50704295, X0704425, X0804127, X0904342, 40904373, A0804001, A0804816, X0904265, 40904407, X0704674, X0704943, A0804485, X0804498, A0804786, A0804849, 50704343, 50704422, X0704677, A0804002, A0904352, 50704126, A0804006, 40804658, 40904376, 50804311, 50804326, 40804467, X0804725, A0804846, 40904398, 50704344, A0804150, 50804168, X0804215, 40804453, X0904164, 40904400, A0904471, 40804200, A0904347, 40904409, A0904703, X0804723, A0804944, 50704423, 40804034, 50804211, 40804471, 40804477, 50804309, 40804433, X0804442, X0704098, 50704144, 50704282, 50704424, X0904073, A0904738, X0804214, A0804948, A0904349, 40904404, 40904413, A0904807, X0704825, A0904808, X0704961, 50804312, X0804370, 40804479, X0804495, A0804847, 40804201, X0804260, 40904369, 40904412, A0704263, 50704442, A0704528, 50804416, X0804724, A0804946, 40904350, 40904351, 50704446, X0704575, X0704826, 40804434, 40804465, 40804615, 40904375, X0604561, X0704819, 40804033, 40804202, 40804421, A0804486, X0904122, 40904378, A0904607, A0904701, 50704443, A0704629, X0704944, 40804431, 40804473, X0804496, 40904322, A0904348, 40904367, A0904476, A0904477, A0904720, A0904775, 50704125, X0704428, 50704441, X0704577, A0704631, 40804032, X0804126, X0804390, 40804472, A0904034, 40904321, 40904333, 40904334, 40904353, A0904696, X0704241, 50804313, 50804457, 40804659, A0804945, 40904379, A0904635, A0904636, 50704570, X0704964, A0804198, A0804203, X0804369, X0804392, 40804418, X0804630, A0804970, X0904121, 40904338, A0904483, A0904484, A0904488, X0704820, X0704945, A0804008, 50804165, 40804203, 50804417, 40804429, A0804568, X0804629, X0904119, X0904120, 40904339, 40904340, 40904374, A0904491, A0904492, 40904853, 50804166, A0804201, 40804432, 40804481, A0804567, X0804631, X0804882, 40904382, A0904719, A0904739, A0904876, 50704445, X0704821, X0804721, 40804913, 40904342, 40904365, A0904495, A0904707, A0904858, A0904875, A0804005, X0804086, 50804213, X0804722, 40904366, A0904497, A0904498, A0904736, A0904774, 40904854, X0704962, A0804004, A0804303, 40804437, A0904346, 40904368, A0904500, A0904860, A0704096, 50704366, 50704444, A0804009, 40904320, A0904698, A0904809, A0904859, 50704027, X0704307, A0804007, A0804149, 50804310, 40804430, X0804441, X0804497, 40904345, 40904364, A0904501, A0904699, X0704673, X0704824, A0804388, X0804689, X0804878, X0904237, 40904385, 50704425, X0704822, 50804418, 40804420, X0804690, A0804757, A0804817, 40904347, 40904348, X0704963, A0804199, A0804246, 40904354, 40904377, 40904386, A0904547.", "firm_fei_number": "1016427", "recalling_firm": "Cordis Corporation", "address_1": "14201 NW 60th Ave", "city": "Miami Lakes", "state": "FL", "postal_code": "33014-2802", "reason_for_recall": "Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004.", "root_cause_description": "Other", "action": "The firm issued a removal of Cypher Product with Incorrect Inventory UBD Sticker letter to its customers in November 2004. The letter instructed them to return the product for credit. It also had an acknowledgement form and requested the consignees complete the acknowledgement form and fax back to Cordis. The firm intends to destroy the returned product.", "product_quantity": "80297 units", "distribution_pattern": "Distributed nation wide.", "openfda": { "pma_number": [ "P110019", "P030025", "P190020", "P020026", "P100023", "P110010", "P950020", "P060033", "P170030", "P160043", "P170008", "P110013", "P150003", "P060008", "P210014", "P070015" ], "registration_number": [ "3015453963", "2011171", "1000121056", "1225687", "3014656749", "3017210488", "3005718570", "3002807315", "3003084171", "3005092783", "3010220595", "2124215", "2134244", "3008132398", "2953200", "2024168", "2183744", "3004091615", "2939561", "2024024", "3016678045", "3010273872", "3002807314", "9681260", "3009380063", "2134265", "8043892", "9710284", "9612164", "3018805824", "3011574793" ], "fei_number": [ "3015453963", "2011171", "1000121056", "3014656749", "3017210488", "3005718570", "3002807315", "3003084171", "3002808050", "3003182398", "3001451463", "3005092783", "3010220595", "2124215", "3002095335", "3002806565", "2024168", "3002807091", "3004091615", "2183744", "3002806434", "2024024", "3016678045", "3010273872", "3002807314", "3004635528", "3009380063", "3001452571", "3003407487", "3018805824", "3011574793" ], "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }