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 - DangerousWhat Should You Do?
- 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, 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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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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, 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Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0488-2021
Related Recalls
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Ureteral dilator, REF RBD014
Coloplast Manufacturing US
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.