Coloplast Manufacturing US, LLC FDA Recalls

21 recalls on file across devices, 0 of them Class I and 20 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

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Product	Reason	Class	Initiated
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, Class IIDec 2, 2024A possible sterility issue was detected in Coloplast's facil	A possible sterility issue was detected in Coloplast's facility on some Coloplast products.	Class IIDevices	Dec 2, 2024
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA612Class IIDec 2, 2024A possible sterility issue was detected in Coloplast's facil	A possible sterility issue was detected in Coloplast's facility on some Coloplast products.	Class IIDevices	Dec 2, 2024
Ureteral dilator, REF RBD014Class IIMar 11, 2024A possible sterility issue (e.g. a breach in sterile packagi	A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some u	Class IIDevices	Mar 11, 2024
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile ProsthesisClass IIMar 1, 2023A decrease in wall thickness has the potential for a prematu	A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard	Class IIDevices	Mar 1, 2023
Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile ProsthesisClass IIMar 1, 2023XXX	XXX	Class IIDevices	Mar 1, 2023
Torosa Saline-Filled Testicular Prosthesis (Size Small)Class IINov 9, 2021Product is mislabeled for size.	Product is mislabeled for size.	Class IIDevices	Nov 9, 2021