{ "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": "216099", "product_res_number": "Z-0144-2026", "event_date_initiated": "2025-09-11", "event_date_posted": "2025-10-10", "recall_status": "Open, Classified", "res_event_number": "97603", "product_code": "JCW", "product_description": "LGX Preconnect with TENACIO Pump with InhibiZone;\nUPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);", "code_info": "1.\tUPN: 72404450 (12CM PS IZ); UDI-DI: 00191506021412; Lot numbers: 1100404813, 1100404817, 1100404818, 1100404819, 1100404820, 1100404821, 1100558512, 1100565086, 1100568924, 1100585061, 1100596471, 1100596473, 1100617027, 1100404816, 1100404814, 1100404815, 1100558509, 1100512315, 1100565093, 1100512387, 1100565088, 1100558508, 1100512313, 1100512388, 1100565084, 1100568927, 1100568926, 1100611812, 1100585059, 1100596478, 1100598982, 1100611809, 1100596324, 1100596477, 1100596472, 1100579740, 1100585066, 1100585064, 1100579739, 1100619111, 1100626304, 1100611810, \n2.\tUPN: 72404451 (15CM PS IZ); UDI-DI: 00191506021429; Lot numbers: 1100480113, 1100480114, 1100480115, 1100480117, 1100480622, 1100480623, 1100480624, 1100480625, 1100480626, 1100480627, 1100480628, 1100511666, 1100511668, 1100511669, 1100511671, 1100511673, 1100558263, 1100558264, 1100558265, 1100563672, 1100563673, 1100563674, 1100563676, 1100563679, 1100563680, 1100584476, 1100584477, 1100584479, 1100584481, 1100584482, 1100584483, 1100592722, 1100592723, 1100592724, 1100592725, 1100592726, 1100592728, 1100595757, 1100595758, 1100595762, 1100595763, 1100595764, 1100595785, 1100595786, 1100595787, 1100595788, 1100609511, 1100609512, 1100609514, 1100613865, 1100613869, 1100613870, 1100613871, 1100613872, 1100613873, 1100614058, 1100614059, 1100614061, 1100614062, 1100614063, 1100614064, 1100614065, 1100615565, 1100615568, 1100615571, 1100615572, 1100615573, 1100636975, 1100636981, 1100636982, 1100636983, 1100656099, 1100656107, 1100666343, 1100666344, 1100666347, 1100666352, 1100670774, 1100670779, 1100683615, 1100683617, 1100683618, 1100683621, 1100685703, 1100685751, 1100685752, 1100686397, 1100686399, 1100686405, 1100687070, 1100687079, 1100692405, 1100692409, 1100695717, 1100695719, 1100695720, 1100695723, 1100723763, 1100723774, 1100563677, 1100558258, 1100592721, 1100609517, 1100592727, 1100595761, 1100609513, 1100636980, 1100614060, 1100614066, 1100636978, 1100592729, 1100584478, 1100584475, 1100595760, 1100595789, 1100615566, 1100695718, 1100666350, 1100656100, 1100685758, 1100656103, 1100685705, 1100685756, 1100666346, 1100692404, 1100685708, 1100695722, 1100692403, 1100685702, 1100656104, 1100685701, 1100656102, 1100685755, 1100692401, 1100656105, 1100686403, 1100723777, \n3.\tUPN: 72404452 (18CM PS IZ); UDI-DI: 00191506021436; Lot numbers: 1100480677, 1100480678, 1100480679, 1100480680, 1100480681, 1100480683, 1100480684, 1100480685, 1100481060, 1100481061, 1100481062, 1100481063, 1100481064, 1100481065, 1100481066, 1100481067, 1100481068, 1100481069, 1100489331, 1100489333, 1100489334, 1100489335, 1100489336, 1100489337, 1100489338, 1100489339, 1100489340, 1100489401, 1100489402, 1100489403, 1100489404, 1100489405, 1100489406, 1100489407, 1100489408, 1100509667, 1100509668, 1100509669, 1100509670, 1100509671, 1100509672, 1100509673, 1100509674, 1100509675, 1100509676, 1100526020, 1100526022, 1100526023, 1100526024, 1100526025, 1100526026, 1100526027, 1100527427, 1100527428, 1100527430, 1100527431, 1100527432, 1100527433, 1100527434, 1100534298, 1100534299, 1100534300, 1100534301, 1100534302, 1100534303, 1100534304, 1100534305, 1100534306, 1100534307, 1100563839, 1100563840, 1100563841, 1100563842, 1100563843, 1100563844, 1100563845, 1100563847, 1100573665, 1100573666, 1100573668, 1100573669, 1100573670, 1100573671, 1100573672, 1100573673, 1100578326, 1100578327, 1100578328, 1100578329, 1100578330, 1100578332, 1100578333, 1100578334, 1100578335, 1100582002, 1100582004, 1100582005, 1100582006, 1100582008, 1100582009, 1100582011, 1100582030, 1100582031, 1100582033, 1100582034, 1100591038, 1100591039, 1100591040, 1100591041, 1100591043, 1100591044, 1100591045, 1100591046, 1100591047, 1100614940, 1100614941, 1100614942, 1100614944, 1100614946, 1100614947, 1100614948, 1100614949, 1100614970, 1100614972, 1100614973, 1100614974, 1100614975, 1100614976, 1100614977, 1100614978, 1100614979, 1100615058, 1100615059, 1100615060, 1100615061, 1100615062, 1100615063, 1100615064, 1100620589, 1100620590, 1100620591, 1100620595, 1100620596, 1100620597, 1100622718, 1100622721, 1100622722, 1100622724, 1100622726, 1100625061, 1100625062, 1100625063, 1100625064, 1100625065, 1100625067, 1100625068, 1100654712, 1100654714, 1100654718, 1100654719, 1100654720, 1100657159, 1100657160, 1100657161, 1100657162, 1100660268, 1100660270, 1100660271, 1100660272, 1100660274, 1100665201, 1100665202, 1100665207, 1100665208, 1100665209, 1100665211, 1100665216, 1100665218, 1100665219, 1100665220, 1100666171, 1100666173, 1100666174, 1100666175, 1100666176, 1100666177, 1100666178, 1100666179, 1100666180, 1100666182, 1100666183, 1100666184, 1100666185, 1100669329, 1100669332, 1100669333, 1100669335, 1100669337, 1100669338, 1100670829, 1100670830, 1100670831, 1100670832, 1100670833, 1100683504, 1100683506, 1100683507, 1100683509, 1100683510, 1100683511, 1100683909, 1100683910, 1100683912, 1100683913, 1100683915, 1100683916, 1100683917, 1100683918, 1100687319, 1100687322, 1100687324, 1100687325, 1100687929, 1100687930, 1100687932, 1100687933, 1100687934, 1100687936, 1100687937, 1100687938, 1100690681, 1100690682, 1100690684, 1100690686, 1100690688, 1100691647, 1100691648, 1100691649, 1100691652, 1100697431, 1100697432, 1100697433, 1100697434, 1100710464, 1100710471, 1100710472, 1100710473, 1100489332, 1100527429, 1100573674, 1100480676, 1100591042, 1100582032, 1100654717, 1100654715, 1100654716, 1100614943, 1100582007, 1100620594, 1100665203, 1100666169, 1100665212, 1100690683, 1100657158, 1100666170, 1100683914, 1100687318, 1100687931, 1100660269, 1100683505, 1100665206, 1100660275, 1100690685, 1100697436, 1100666172, 1100691656, 1100660273, 1100683512, 1100657163, 1100710468, \n4.\tUPN: 72404453 (21CM PS IZ); UDI-DI: 00191506021443; Lot numbers: 1100527254, 1100527256, 1100547607, 1100547610, 1100547613, 1100547615, 1100553676, 1100553680, 1100615799, 1100615802, 1100615806, 1100615807, 1100615808, 1100627337, 1100627340, 1100628656, 1100628657, 1100628658, 1100628659, 1100632123, 1100632124, 1100636857, 1100678269, 1100687081, 1100687084, 1100713232, 1100547611, 1100527260, 1100527263, 1100542413, 1100553678, 1100542412, 1100628651, 1100615800, 1100615805, 1100636859, 1100636860, 1100615801, 1100628655, 1100636864, 1100628650, 1100627339, 1100636865, 1100636862, 1100678264, 1100678267, 1100692151, 1100687083, 1100692146, \n5.\tUPN: 72404455 (12CM IP IZ); UDI-DI: 00191506021450; Lot numbers: 1100491487, 1100573783, 1100581262, 1100581263, 1100581266, 1100581297, 1100573778, 1100573776, 1100573782, 1100491491, 1100569277, 1100573781, 1100491492, 1100570202, 1100491486, 1100596863, 1100581305, 1100596861, 1100581304, 1100596862, 1100581306, 1100581300, 1100584903, 1100596864, 1100581271, 1100596858, 1100581302, 1100581269, 1100584900, 1100581301, 1100584899, 1100581267, 1100584897, 1100679354, 1100679350,\n6.\tUPN: 72404456 (15CM IP IZ); UDI-DI: 00191506021467; Lot numbers: 1100481228, 1100481229, 1100481230, 1100481231, 1100481233, 1100481234, 1100481235, 1100481237, 1100629264, 1100629272, 1100629273, 1100651201, 1100651205, 1100651210, 1100651212, 1100651213, 1100651214, 1100651215, 1100655196, 1100668323, 1100668324, 1100670786, 1100670790, 1100673337, 1100673338, 1100673343, 1100673344, 1100676819, 1100690779, 1100690780, 1100690787, 1100690790, 1100716504, 1100716521, 1100481236, 1100481232, 1100629266, 1100651211, 1100651209, 1100655194, 1100655202, 1100651204, 1100655197, 1100655193, 1100651203, 1100651217, 1100676816, 1100690792, 1100668322, 1100690783, 1100690794, 1100676817, 1100670788, 1100670785, 1100716522, 1100716514, 1100716509, 1100716512,\n7.\tUPN: 72404457 (18CM IP IZ); UDI-DI: 00191506021474; Lot numbers: 1100398489, 1100398490, 1100398491, 1100398492, 1100398493, 1100398494, 1100398495, 1100398496, 1100481311, 1100481312, 1100481314, 1100481316, 1100481317, 1100481318, 1100481319, 1100481320, 1100535385, 1100535386, 1100535387, 1100535388, 1100535389, 1100535390, 1100535391, 1100535392, 1100613884, 1100613885, 1100613886, 1100613887, 1100613888, 1100613889, 1100613890, 1100613891, 1100613892, 1100629807, 1100629809, 1100629810, 1100629811, 1100629812, 1100629813, 1100629814, 1100651802, 1100651803, 1100651804, 1100651808, 1100651837, 1100651838, 1100651839, 1100651840, 1100651845, 1100655625, 1100655626, 1100655627, 1100655628, 1100655629, 1100655631, 1100655632, 1100655633, 1100655634, 1100655710, 1100655711, 1100655712, 1100655713, 1100655716, 1100655717, 1100655718, 1100657357, 1100657358, 1100657359, 1100657361, 1100657364, 1100667614, 1100667615, 1100667616, 1100667617, 1100667618, 1100667619, 1100667620, 1100667623, 1100667624, 1100667626, 1100667627, 1100667628, 1100667631, 1100668311, 1100668313, 1100668315, 1100668316, 1100668317, 1100695663, 1100695665, 1100712622, 1100712630, 1100714749, 1100726414, 1100726417, 1100726418, 1100726419, 1100481315, 1100481313, 1100651807, 1100655714, 1100655709, 1100667613, 1100695659, 1100667630, 1100657360, 1100668312, 1100695666, 1100668318, 1100714743, 1100714751, 1100714748, 1100726416, 1100712631,\n8.\tUPN: 72404458 (21CM IP IZ); UDI-DI: 00191506021481; Lot numbers: 1100401206, 1100401207, 1100401208, 1100401209, 1100401210, 1100401211, 1100401212, 1100401213, 1100401214, 1100527092, 1100527095, 1100527100, 1100538045, 1100545960, 1100545961, 1100545968, 1100556132, 1100556135, 1100556136, 1100579477, 1100579479, 1100579480, 1100579482, 1100579483, 1100579488, 1100579494, 1100603659, 1100603662, 1100620429, 1100620431, 1100621446, 1100621448, 1100621450, 1100658988, 1100658995, 1100658996, 1100688010, 1100688011, 1100688012, 1100579484, 1100579493, 1100556134, 1100579478, 1100579487, 1100579491, 1100556137, 1100579476, 1100527096, 1100579489, 1100527097, 1100556138, 1100603665, 1100603658, 1100603661, 1100621451, 1100621443, 1100621449, 1100621445, 1100636814, 1100603660, 1100658991, 1100688007, 1100658989, 1100658997, 1100688008, 1100688005;", "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": "Renee Archie\n508-683-4523", "reason_for_recall": "The potential for devices to experience inflation and/or deflation performance issues or difficulties.", "root_cause_description": "Nonconforming Material/Component", "action": "On September 11, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: For implanted devices: If the device is working properly, no action is required. Further evaluation is recommended for patients who were implanted with an affected device AND are having difficulty inflating or deflating the device.\n- Check inventory for affected product and return any unused devices. Immediately cease further distribution or use of any unused affected devices. Please pass this notice to any healthcare professional from your organization that needs to be aware and to any organization\nwhere the potentially affected devices have been transferred. Please provide Boston Scientific with details of any affected\ndevices that have been transferred to another organization.", "product_quantity": "490 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Canada.", "openfda": { "pma_number": [ "N970012" ], "device_name": "Prosthesis, Penis, Inflatable", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.3350", "device_class": "3", "registration_number": [ "3013987875", "3005099803", "3013960851", "2124215" ], "fei_number": [ "3013987875", "3005099803", "3013960851", "2124215" ] } } ] }