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Coloplast Manufacturing US Recalls
28 recalls on record · May 29, 2013 to January 22, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 22, 2025Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222,
Hazard: A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
January 22, 2025Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA612
Hazard: A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
April 10, 2024Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Ureteral dilator, REF RBD014
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
Hazard: XXX
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
Hazard: 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.
April 19, 2023Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
Hazard: 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.
December 29, 2021Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Torosa Saline-Filled Testicular Prosthesis (Size Small)
Hazard: Product is mislabeled for size.
December 2, 2020Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are consider
Hazard: Potential increased occurrence of pump fracture over the lifetime of the device.
April 27, 2016Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermi
Hazard: Coloplast Corp. is voluntarily recalling a single lot of Self-Cath Pediatric French Size CH 06 catheters because a small portion of the lot was identified to have missing eyelets. This recall is based upon a complaint Coloplast received regarding a catheter malfunction.
May 6, 2015Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Gen
Hazard: Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm. The device size is printed directly on the individual prosthesis tray during the packaging process and states the correct size, 9.5 mm.
November 5, 2014Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
Hazard: Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
November 5, 2014Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adh
Hazard: Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
June 12, 2013Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex
Hazard: Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year expiration date.
May 29, 2013Medical DevicesFDA
Coloplast Manufacturing US, LLC recalls Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Hazard: Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.