Coloplast Manufacturing US, LLC
20 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Coloplast Manufacturing US, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-01-22FDA-DeviceClass IIX-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
- 2025-01-22FDA-DeviceClass IIFolysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
- 2024-04-10FDA-DeviceClass IIUreteral dilator, REF RBD014
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.
- 2023-04-19FDA-DeviceClass IITitan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
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- 2023-04-19FDA-DeviceClass IITitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- 2023-04-19FDA-DeviceClass IITitan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
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