Recall archive
10 recalls · page 1 of 1
Reported Jan 22, 2025
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
Matched: Brand · Reason for recall — A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 10, 2024
Ureteral dilator, REF RBD014
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
Matched: Brand · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported Apr 19, 2023
Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
Matched: Brand — 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…
16 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
Matched: Brand — Product is mislabeled for size.
FDA (openFDA device enforcement)
Reported Dec 2, 2020
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
Matched: Brand — Potential increased occurrence of pump fracture over the lifetime of the device.
FDA (openFDA device enforcement)
Reported Apr 27, 2016
Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
Matched: Brand · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported May 6, 2015
Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported Nov 5, 2014
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Coloplast Manufacturing US, LLC
Matched: Brand · Reason for recall — Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2013
Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
Matched: Brand · Reason for recall — Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year…
FDA (openFDA device enforcement)
Reported May 29, 2013
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Coloplast Manufacturing US, LLC
Matched: Brand · Product · Product details · Reason for recall — Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in…
FDA (openFDA device enforcement)
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