Coloplast Manufacturing Us recalls
Coloplast Manufacturing Us appears in 28 official U.S. recall notices indexed by RecallRadar, most recently on 2025-01-22.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 28 |
|---|---|
| Published | 2013-05-29 to 2025-01-22 |
| By agency | FDA Device (28) |
| By classification | Class II (27), Class III (1) |
| By status | ongoing (20), terminated (8) |
| Distribution named in notices | AZ, GA, KS, KY, LA, MD, MI, MN, MO, MS, OH, PR, RI, TN, TX, US, VA, WA |
Recalls
- X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6…
FDA Device · Class II · 2025-01-22 · Coloplast Manufacturing Us
Reason: A possible sterility issue was detected in Coloplast's facility on some Coloplast products. - Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124,…
FDA Device · Class II · 2025-01-22 · Coloplast Manufacturing Us
Reason: A possible sterility issue was detected in Coloplast's facility on some Coloplast products. - Ureteral dilator, REF RBD014
FDA Device · Class II · 2024-04-10 · Coloplast Manufacturing Us
Reason: 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… - Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan Pump Assembly, Catalog Number 5177701400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: XXX - Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan Touch Pump, Catalog Numbers 5177502400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
Reason: 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 prosthesi… - Torosa Saline-Filled Testicular Prosthesis (Size Small)
FDA Device · Class II · 2021-12-29 · Coloplast Manufacturing Us
Reason: Product is mislabeled for size. - Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates…
FDA Device · Class II · 2020-12-02 · Coloplast Manufacturing Us
Reason: Potential increased occurrence of pump fracture over the lifetime of the device. - Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306
FDA Device · Class II · 2016-04-27 · Coloplast Manufacturing Us
Reason: 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 C… - Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250
FDA Device · Class II · 2015-05-06 · Coloplast Manufacturing Us
Reason: 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… - Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400
FDA Device · Class III · 2014-11-05 · Coloplast Manufacturing Us
Reason: Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled. - Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174
FDA Device · Class II · 2014-11-05 · Coloplast Manufacturing Us
Reason: Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled. - Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400
FDA Device · Class II · 2013-06-12 · Coloplast Manufacturing Us
Reason: 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. - Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark
FDA Device · Class II · 2013-05-29 · Coloplast Manufacturing Us
Reason: 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.