The Recall Desk

Manufacturer

Coloplast Manufacturing US, LLC

28 recalls in our database name Coloplast Manufacturing US, LLC as the manufacturing or recalling firm.

What the numbers show

Total
28
Critical
0
Severe
0
Most recent
2025-01-22

Of the 28 recalls from Coloplast Manufacturing US, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 28

  • HighFDA (Devices)·Z-0845-2025·2025-01-22

    X-Flow Prostatectomy Catheter Recalled for Possible Sterility Defect

    Coloplast is recalling 36,369 X-Flow prostatectomy catheters due to a possible sterility issue detected at its manufacturing facility.

    Product
    X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0844-2025·2025-01-22

    Folysil Silicone Foley Catheters Recalled for Possible Sterility Issue

    Coloplast recalls Folysil Silicone Foley Catheters due to a possible sterility defect detected at the manufacturing facility. The affected units may not maintain proper sterilization, posing a risk of infection.

    Product
    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA642
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2024·2024-04-10

    Coloplast Ureteral Dilators Recalled Due to Sterile Packaging Issue

    Coloplast Manufacturing is recalling 710 ureteral dilators due to a possible breach in sterile packaging detected during facility testing. The devices are distributed across multiple US states.

    Product
    Ureteral dilator, REF RBD014
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1362-2023·2023-04-19

    Inflatable Penile Prosthesis Pump Risk of Premature Failure

    Coloplast is recalling Titan Touch NB Infr Zero 18cm inflatable penile prostheses due to decreased pump wall thickness that may cause premature device failure after repeated use.

    Product
    Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled Due to Pump Failure Risk

    Coloplast is recalling the Titan Touch NB Infr Zero 16cm inflatable penile prosthesis due to decreased wall thickness in the pump, which may cause premature failure with repeated use.

    Product
    Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1365-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Potential Pump Failure Risk

    Coloplast is recalling certain Titan NB Infra Zero Ang 16cm inflatable penile prostheses due to thinner-than-standard pump wall thickness that could lead to premature pump failure.

    Product
    Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2023·2023-04-19

    Inflatable Penile Prosthesis Risk of Premature Pump Failure

    Coloplast's Titan Touch NB Scrot Zero 16cm prosthesis has been recalled due to decreased wall thickness that could cause premature pump failure. The defect was identified in specific lot units distributed worldwide.

    Product
    Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1371-2023·2023-04-19

    Inflatable Penile Prosthesis Recall Due to Potential Pump Failure Risk

    Coloplast is recalling certain inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure. No injuries have been reported.

    Product
    Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1359-2023·2023-04-19

    Titan Touch Pump Inflatable Prosthesis Recalled for Structural Defect Risk

    Coloplast Manufacturing is recalling Titan Touch Pump inflatable penile prostheses due to manufacturing defect causing decreased wall thickness that could lead to premature device failure.

    Product
    Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2023·2023-04-19

    Inflatable penile prosthesis recalled due to pump wall thickness manufacturing defect

    Coloplast is recalling Titan NB inflatable penile prostheses with reduced pump wall thickness that may cause premature pump failure during normal use.

    Product
    Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1364-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Premature Pump Failure Risk

    Coloplast is recalling 13 units of the Titan Touch NB Scrot Zero 18cm inflatable penile prosthesis due to decreased wall thickness that could cause premature pump failure.

    Product
    Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Potential Pump Failure Risk

    Coloplast is recalling 15 units of the Titan Touch Infr Zero Ang inflatable penile prosthesis (Lot Numbers 8849582, 8849603, 8904185) worldwide due to decreased wall thickness that may cause premature pump failure.

    Product
    Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1360-2023·2023-04-19

    Inflatable Prosthesis Pump Assembly Recalled for Premature Failure Risk

    Coloplast is recalling 9 Titan Pump Assemblies for inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure during normal use.

    Product
    Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Risk of Premature Pump Failure

    Coloplast is recalling Titan Touch inflatable penile prostheses with reduced pump wall thickness, which could cause premature failure during use. The defect affects 8 units distributed across the US and multiple European countries.

    Product
    Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled Due to Risk of Premature Pump Failure

    Coloplast is recalling Titan Touch Scro Zero Ang 20cm penile prostheses due to decreased wall thickness that could cause premature pump failure. Patients should contact their healthcare provider for guidance.

    Product
    Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1369-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Premature Pump Failure Risk

    Coloplast is recalling Titan Touch Scro Zero Ang 16cm prostheses (Lot 8840677) due to decreased wall thickness that may cause premature pump failure. Affected devices were distributed worldwide, including throughout the US.

    Product
    Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2023·2023-04-19

    Titan Inflatable Penile Prosthesis Pump Failure Risk Recall

    Coloplast is recalling the Titan 0-Deg Infrapubic 20 Cm inflatable penile prosthesis due to reduced wall thickness in the pump that could cause premature failure. No injuries have been reported.

    Product
    Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1375-2023·2023-04-19

    Titan inflatable penile prosthesis recalled due to premature pump failure risk

    Coloplast is recalling the Titan 0-Deg inflatable penile prosthesis due to decreased pump wall thickness that may cause premature device failure. The recall affects 23 units distributed worldwide.

    Product
    Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1373-2023·2023-04-19

    Titan Penile Prosthesis Recalled Due to Premature Pump Failure Risk

    Coloplast Manufacturing is recalling the Titan 0-Deg Scrotal 18 Cm inflatable penile prosthesis (25 units) due to decreased wall thickness that may cause premature pump failure. Patients with affected lot numbers should contact their healthcare provider.

    Product
    Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1374-2023·2023-04-19

    Inflatable Penile Prosthesis Titan Recalled Coloplast Manufacturing Class II

    Coloplast Manufacturing recalls 20 units of Titan 0-Deg Scrotal inflatable penile prosthesis (Lot Numbers 8849601, 8849600, 8849621) with worldwide distribution. The specific reason for the recall is not specified in FDA records.

    Product
    Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0413-2022·2021-12-29

    Testicular Prosthesis Recalled Due to Incorrect Size Labeling

    Coloplast Manufacturing is recalling Torosa Saline-Filled Testicular Prosthesis (Size Small) due to incorrect size labeling. Nineteen units were distributed in the US and Canada.

    Product
    Torosa Saline-Filled Testicular Prosthesis (Size Small)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2021·2020-12-02

    Coloplast Titan Pump Recall for Potential Device Fracture

    Coloplast is recalling 8,962 Titan Pump units due to a potential increased occurrence of pump fracture over the device's lifetime.

    Product
    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1525-2016·2016-04-27

    Coloplast Recalls Pediatric Catheters Due to Missing Eyelets

    Coloplast is voluntarily recalling a single lot of Self-Cath Pediatric Catheters because some units have missing eyelets, which can cause catheter malfunction.

    Product
    Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine ret
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1538-2015·2015-05-06

    Coloplast Genesis Malleable Penile Prosthesis Mislabeled Size Recall

    Coloplast is recalling 11 units of the 9.5 mm Genesis Malleable Penile Prosthesis because the retail box and patient labels incorrectly state the size as 9 mm.

    Product
    Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2015·2014-11-05

    Coloplast Conveen Urine Collection Leg Bag Recalled for Seam Leakage

    Coloplast is recalling Conveen Urine Collection Leg Bags due to potential leakage from the bag seam when filled.

    Product
    Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
    Category
    Medical Device
    Distribution
    Distributed nationwide