--- title: "Coloplast Manufacturing US, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Coloplast Manufacturing US, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/coloplast-manufacturing-us-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Coloplast Manufacturing US, LLC recall records **20** reported ongoing 21 records in this archive. Latest source date Dec 2, 2024. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Dec 2, 2024 FDA device enforcement ### [Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316...](https://isitonrecall.com/recall/fda-device-z-0844-2025-folysil-silicone-foley-catheters-device-reference-numbers-aa6106-aa6108-aa6110-aa6112-aa6114-aa6116/) A possible sterility issue was detected in Coloplast's facility on some Coloplast products. Class II Reported ongoing Distribution: US Nationwide. Canada. [Official source for Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0844-2025%22) Dec 2, 2024 FDA device enforcement ### [X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, A...](https://isitonrecall.com/recall/fda-device-z-0845-2025-x-flow-prostatectomy-catheter-device-reference-numbers-ab6022-ab6024-ab6118-ab6120-ab6122-ab6124-ab6/) A possible sterility issue was detected in Coloplast's facility on some Coloplast products. Class II Reported ongoing Distribution: US Nationwide. Canada. [Official source for X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, A...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0845-2025%22) Mar 11, 2024 FDA device enforcement ### [Ureteral dilator, REF RBD014](https://isitonrecall.com/recall/fda-device-z-1463-2024-ureteral-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. Class II Reported ongoing Distribution: US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA [Official source for Ureteral dilator, REF RBD014](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1463-2024%22) Mar 1, 2023 FDA device enforcement ### [Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1359-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1359-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1360-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1360-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1361-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1361-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1362-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1362-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1363-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1363-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1364-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1364-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1365-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1365-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1366-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1366-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1367-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1367-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1368-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1368-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1369-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1369-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1370-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1370-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1371-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1371-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1372-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1372-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1373-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1373-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1374-2023-titan-0-deg-scrotal-20-cm-catalog-number-es89202400-inflatable-penile-prosthesis/) XXX Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1374-2023%22) Mar 1, 2023 FDA device enforcement ### [Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis](https://isitonrecall.com/recall/fda-device-z-1375-2023-titan-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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. [Official source for Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1375-2023%22) ## Reasons in these listed records - A possible sterility issue was detected in Coloplast's facility on some Coloplast products. - 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. - 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. - XXX These examples come from this result page and are not a ranking of every recall reason. ## Checking Coloplast Manufacturing US, LLC ### Is there a recall on coloplast manufacturing us, llc right now? This archive contains 21 records, including 20 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Coloplast Manufacturing US, LLC](https://isitonrecall.com/check/?q=Coloplast%20Manufacturing%20US%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)