Titan Pump - Product Usage: indicated for male patients recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

5585215, 5637061, 5887656, 5887660, 5887662, 6044855, 6121948, 6203696, 6256289, 6281814, 6282077, 6293595, 6340949, 6397321, 6450370, 6467920, 6523184, 6563685, 6565025, 6620080, 6625337, 6713215, 6741559, 6741597, 6759251, 6759252, 6778965, 6781635, 6828420, 6891543, 6891647, 6945902, 6949447, 6993341, 7023392, 7050985, 7051006, 7108209, 7109949, 7149995, 7150019, 7150020, 7180121, 7180122, 7261757, 7263766, 7263791, 7289306, 7299921, 7348362, 7356189, 7433677, 6408870, 6563692, 6942524, 6993351, 7045704, 7261764, 6408871, 6563693, 6942525, 6993352, 7045705, 7289317, 7338041, 5813224, 5817083, 5852938, 6050537, 6663007, 6778974, 6828426, 6949393, 6993357, 7150000, 7338043, 5813225, 5817084, 5852939, 6050538, 6337898, 6461064, 6563696, 6741565, 6778975, 6834142, 6883290, 6949394, 7007420, 7050992, 7150001, 7261766, 7289322, 7338044, 5736817, 6337896, 6523195, 6563694, 6945912, 6993353, 7045706, 7289318, 5584179, 6337897, 6523196, 6563695, 6945913, 6993354, 7045707, 7180852, 7261765, 7338042, 5742639, 5742640, 5758714, 5852940, 5907315, 6125002, 6620085, 6674084, 6741603, 6778976, 6828427, 6834143, 6993358, 7150002, 7180853, 5742641, 5742642, 5852941, 5907316, 6125003, 6563697, 6620086, 6741566, 6778977, 6828428, 6834144, 6883291, 7007421, 7150003, 7180854, 7261767, 5637052, 6337887, 6408865, 6563686, 6759253, 6993342, 7045695, 7289307, 7348363, 6121901, 6293550, 6337888, 6450603, 6523235, 6565026, 6625338, 6741560, 6778966, 6781636, 6837790, 6883286, 6949382, 7050965, 7108091, 7261758, 7289308, 7348364, 5493118, 5584171, 5585228, 5616471, 5953308, 6000536, 6046592, 6121902, 6203655, 6256291, 6257005, 6287824, 6287825, 6293551, 6293552, 6337889, 6401124, 6401857, 6408866, 6450604, 6450605, 6461060, 6523185, 6523236, 6563687, 6565095, 6625339, 6625389, 6674051, 6741561, 6741631, 6741632, 6778967, 6781616, 6781637, 6837840, 6837841, 6883287, 6886577, 6945903, 6949383, 7045696, 7050966, 7108122, 7108210, 7150021, 7150022, 7180870, 7180892, 7263767, 7289309, 7299972, 7348365, 7356190, 7432367, 7432368, 5585205, 5637053, 5673510, 5748875, 5817200, 5817206, 5923738, 5953309, 5954002, 6000537, 6046593, 6121903, 6157434, 6203656, 6203657, 6203725, 6203726, 6256292, 6257006, 6287826, 6293553, 6337890, 6340891, 6401125, 6401858 ,6401885, 6461061, 6467921, 6523186, 6523237, 6526312, 6565096, 6565097, 6565133, 6625340, 6625390, 6662998, 6674247, 6674289, 6715292, 6741598, 6741633, 6778968, 6781617, 6828421, 6834138, 6837791, 6837842, 6883288, 6891544, 6891649, 6945904, 6949384, 6993343, 7007443, 7045697, 7050986, 7051007, 7108092, 7108123, 7108211, 7149996, 7150023, 7180871, 7180893, 7263768, 7263792, 7289310, 7299973, 7348366, 7356435, 7432369, 7432370, 7432371, 5493073, 5585206, 5637054, 5637137, 5817253, 5953310, 5988740, 6046594, 6121904, 6157435, 6203658, 6247927, 6256293, 6287827, 6293554, 6340892, 6401126, 6401859, 6450606, 6450607, 6523187, 6565027, 6565098, 6565099, 6565134, 6565135, 6625341, 6674248, 6741562, 6741599, 6741634, 6759254, 6781592, 6781638, 6828422, 6949385, 6949386, 6949448, 6993344, 7007415, 7007444, 7012748, 7045698, 7108093, 7108094, 7108124, 7150024, 7150025, 7180872, 7263769, 7299901, 7299902, 7338036, 7348367, 7432372, 5584172, 6293585, 6563688, 6741635, 6759255, 6786417, 6993345, 7045699, 7289311, 7348368, 5585207, 5585208, 5860331, 5953311, 5953965, 5988741, 6046595, 6247928, 6337891, 6388057, 6401860, 6523188, 6526313, 6563689, 6565100, 6625342, 6663000, 6674052, 6741563, 6837792, 6886579, 6945905, 7007416, 7050967, 7108095, 7180873, 7263770, 5493076, 5585210, 5585231, 5585232, 5616472, 5637057, 5673512, 5748877, 5748878, 5852948, 5953313, 5953314, 6000539, 6046600, 6046671, 6121906, 6121950, 6125000, 6157438, 6203662, 6203698, 6247933, 6256295, 6257010, 6287830, 6293558, 6293559, 6337895, 6340896, 6401129, 6401862, 6408869, 6450609, 6461063, 6523192, 6523240, 6526318, 6565031, 6565139, 6565140, 6625344, 6625394, 6674055, 6674251, 6674292, 6713220, 6726455, 6741602, 6759257, 6781595, 6781596, 6781619, 6828425, 6834141, 6837795, 6837845, 6837846, 6886582, 6891549, 6891655, 6945908, 6945909, 6949389, 6949390, 6949450, 6949451, 6993347, 7007419, 7007448, 7012750, 7023394, 7045702, 7050970, 7050988, 7051010, 7108098, 7108127, 7108214, 7150032, 7180848, 7180877, 7180878, 7180896, 7263775, 7263776, 7263795, 7263796, 7263797, 7289314, 7299904, 7299977, 7299978, 73380387348370, 7356438, 7432376, 5493076, 5585210, 5585231, 5585232, 5616472, 5637057, 5673512, 5748877, 5748878, 5852948, 5953313, 5953314, 6000539, 6046600, 6046671, 6121906, 6121950, 6125000, 6157438, 6203662, 6203698, 6247933, 6256295, 6257010, 6287830, 6293558, 6293559, 6337895, 6340896, 6401129, 6401862, 6408869, 6450609, 6461063, 6523192, 6523240, 6526318, 6565031, 6565139, 6565140, 6625344, 6625394, 6674055, 6674251, 6674292, 6713220, 6726455, 6741602, 6759257, 6781595, 6781596, 6781619, 6828425, 6834141, 6837795, 6837845, 6837846, 6886582, 6891549, 6891655, 6945908, 6945909, 6949389, 6949390, 6949450, 6949451, 6993347, 7007419, 7007448, 7012750, 7023394, 7045702, 7050970, 7050988, 7051010, 7108098, 7108127, 7108214, 7150032, 7180848, 7180877, 7180878, 7180896, 7263775, 7263776, 7263795, 7263796, 7263797, 7289314, 7299904, 7299977, 7299978, 73380387348370, 7356438, 7432376, 5493076, 5585210, 5585231, 5585232, 5616472, 5637057, 5673512, 5748877, 5748878, 5852948, 5953313, 5953314, 6000539, 6046600, 6046671, 6121906, 6121950, 6125000, 6157438, 6203662, 6203698, 6247933, 6256295, 6257010, 6287830, 6293558, 6293559, 6337895, 6340896, 6401129, 6401862, 6408869, 6450609, 6461063, 6523192, 6523240, 6526318, 6565031, 6565139, 6565140, 6625344, 6625394, 6674055, 6674251, 6674292, 6713220, 6726455, 6741602, 6759257, 6781595, 6781596, 6781619, 6828425, 6834141, 6837795, 6837845, 6837846, 6886582, 6891549, 6891655, 6945908, 6945909, 6949389, 6949390, 6949450, 6949451, 6993347, 7007419, 7007448, 7012750, 7023394, 7045702, 7050970, 7050988, 7051010, 7108098, 7108127, 7108214, 7150032, 7180848, 7180877, 7180878, 7180896, 7263775, 7263776, 7263795, 7263796, 7263797, 7289314, 7299904, 7299977, 7299978, 73380387348370, 7356438, 7432376, 5622572, 5491299, 5585227, 5491300, 5531593, 5531594, 5531595, 5531596, 5584161.

Product

Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for…

Recalling firm

Coloplast Manufacturing US, LLC

Quantity

8,962 units

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of DK, ES, JP.

Recall date

December 2, 2020

Classification

Class II

Status

Terminated

Agency

FDA (device)