Coloplast Manufacturing Us, Llc
Minneapolis, MN
This page shows every FDA and USDA recall linked to Coloplast Manufacturing Us, Llc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
33
Total Recalls
2009
First Recall
2025
Most Recent
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6...
Jan 10, 2025
· Device
Open, Classified
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220...
Jan 10, 2025
· Device
Open, Classified
Ureteral dilator, REF RBD014
Apr 2, 2024
· Device
Open, Classified
Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
Apr 12, 2023
· Device
Open, Classified
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Nov 9, 2021
· Device
Terminated
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who ar...
Oct 23, 2020
· Device
Terminated
Self-Cath Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306.
Product Usage:
The Self-Cath i...
Mar 22, 2016
· Device
Terminated
Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250.
Product Usage:
The Colopl...
Apr 27, 2015
· Device
Terminated
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174.
Urine Collection Bag.
Oct 30, 2014
· Device
Terminated
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU.
Biatain Super...
Oct 24, 2014
· Device
Terminated
Digitex Absorbable Polydiaxanone Suture, Size 2-0.
Catalog Number / Code of product: 52031, 5203101400.
The...
Jun 5, 2013
· Device
Terminated
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
May 20, 2013
· Device
Terminated
Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only, Manufacturer...
May 2, 2012
· Device
Terminated
Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with window, 100 mm , St...
Sep 9, 2011
· Device
Terminated
SpeediCath , SpeediCath with Accessories
Coloplast Corp -MN, Sterile R, Manufacturer Coloplast -A/S 3050 Denma...
Jun 3, 2011
· Device
Terminated
SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer Coloplast -A/S 3050 Denmark...
Jun 3, 2011
· Device
Terminated
Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400....
Nov 10, 2009
· Device
Terminated