Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Coloplast Manufacturing US, LLC
Reason for Recall:
Potential increased occurrence of pump fracture over the lifetime of the device.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0488-2021

Related Recalls

A possible sterility issue was detected in Coloplast's facility on some Coloplast products.

Dec 2, 2024 Surgical Instruments Nationwide View Details →

Ureteral dilator, REF RBD014

Coloplast Manufacturing US

Class I - Dangerous

A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.

Mar 11, 2024 Other Medical Devices View Details →