Every recall we track for Coloplast Manufacturing US, LLC — 22 in all — plus the complaints and injury reports the public filed about them.
Coloplast recalls specific Folysil Silicone Foley Catheters with Device Reference Numbers AA6106 to AA6C24 due to a possible sterility issue detected in their facility. Affected units include listed lot numbers and GTINs.
Coloplast recalls X-Flow prostatectomy catheters with specific device reference numbers and lot numbers due to a possible sterility issue detected in their facility.
Coloplast recalls ureteral dilator products REF RBD014 with possible sterility packaging breaches. Affected units have specific lot codes; contact for remedy.
Coloplast recalls Titan NB Infra Zero Ang 16cm inflatable penile prostheses (EN88162400) due to potential premature pump failure from decreased wall thickness. Affected units include specific catalog numbers and lot numbers.
Coloplast recalls Titan Touch Pump (catalog 5177502400) due to potential premature pump failure from decreased wall thickness. Affected units include specific lot numbers for inflatable penile prostheses.
Coloplast recalls Titan 0-Deg Scrotal 18 Cm inflatable penile prostheses with potential premature pump failure due to wall thickness issues. Affected units have specific catalog numbers and lot numbers.
Coloplast recalls Titan Touch NB Infr Zero 18cm inflatable penile prostheses with potential premature pump failure due to wall thickness issues. Affected units have specific catalog numbers and lot numbers.
Coloplast recalls Titan 0-Deg Scrotal 22 Cm inflatable penile prostheses with potential premature pump failure due to wall thickness issues. Affected units include specific catalog numbers and lot numbers. Consumers should contact Coloplast for details.
Coloplast recalls Titan Touch Infr Zero Ang 22cm inflatable penile prostheses with potential premature pump failure due to wall thickness issues. Affected units include specific catalog numbers and lot numbers.
Coloplast recalls Titan 0-Deg Infrapubic 20 Cm inflatable penile prostheses due to potential premature pump failure from decreased wall thickness. Affected units have specific catalog numbers and lot numbers.
Coloplast recalls Titan Touch NB Infr Zero 16cm inflatable penile prostheses (Catalog EN28162400) due to potential premature pump failure from reduced wall thickness. Affected units have specific lot numbers and UDI/DI codes.
Coloplast recalls specific inflatable penile prostheses due to risk of serious injury. Affected units have catalog number ES89202400 and lot numbers 8849600-8849621. Consumers should contact Coloplast for details.
Coloplast recalls Titan Touch NB Scrot Zero 16cm inflatable penile prostheses (Catalog EN29162400) due to potential premature pump failure from reduced wall thickness. Affected units have specific lot numbers and UDI/DI codes.
Coloplast recalls Titan Touch Infr Zero Ang 18cm inflatable penile prostheses with potential premature pump failure due to wall thickness issues. Affected units have specific catalog and lot numbers.
Coloplast recalls Titan Touch Scro Zero Ang 16cm inflatable penile prostheses (ES29162400) due to potential premature pump failure from reduced wall thickness. Affected units have specific catalog and lot numbers.
Coloplast recalls Titan Touch Scro Zero Ang 20cm inflatable penile prostheses with potential premature pump failure due to wall thickness issues. Affected units have specific catalog and lot numbers.
Coloplast recalls Titan Touch Scro Zero Ang 22cm inflatable penile prostheses (ES29222400) due to potential premature pump failure from reduced wall thickness. Affected units include specific lot numbers and UDI/DI codes.
Coloplast recalls Titan Touch NB Scrot Zero 18cm inflatable penile prostheses with potential premature pump failure due to wall thickness issues. Affected units have specific catalog and lot numbers.
Coloplast recalls Titan NB Scrotal Zero Ang 18cm inflatable penile prostheses (EN88182400) due to potential premature pump failure from decreased wall thickness. Affected units have specific catalog and lot numbers.
Coloplast recalls Titan Pump Assembly (Catalog 5177701400) due to potential premature pump failure from decreased wall thickness. Affected units include specific lot numbers for inflatable penile prostheses.
Coloplast recalls small saline-filled testicular prosthesis units due to size mislabeling. Affected units may not fit properly, but no injury risk is reported.
Coloplast recalls Titan Pump devices for men with erectile dysfunction implants due to potential increased fracture risk over time. No remedy specified in official notice.
