PlainRecalls

Coloplast Manufacturing US, LLC

Compiled from official public sources by the publisher.

28 recalls on record · Latest: Jan 22, 2025

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Agency notice ledger

Federal filing book Coloplast Manufacturing US,… MID-BOOK · SINGLE-AGENCY

#584 of 14,151 · 28 notices · 0.027% archive

  • BOOK 28 notices
  • RANK #584 of 14,151
  • SHARE 0.027% archive
  • AGENCY FDA Devices (28)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jan 22, 2025
  • PHOTO Apollo Care, LLC

Nearest notice-volume peer: Apollo Care, LLC (0 notice gap)

Coloplast Manufacturing US, LLC accounts for about 0.027% of the 104,423-notice archive on 28 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Coloplast Manufacturing US,…'s standing among 14,151 recalling firms

Coloplast Manufacturing US, LLC ranks 584th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Coloplast Manufacturing US,… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

28 584th of 14151 higher than 13,557 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Coloplast Manufacturing US,… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Coloplast Manufacturing US, LLC holds about 0.027% of archive notices alongside 28 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jan 22, 2025

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.
FDA Devices Moderate Jan 22, 2025

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, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Devices Moderate Apr 10, 2024

Ureteral dilator, REF RBD014
FDA Devices Moderate Apr 19, 2023

Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
FDA Devices Moderate Apr 19, 2023

Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
FDA Devices Moderate Dec 29, 2021

Torosa Saline-Filled Testicular Prosthesis (Size Small)
FDA Devices Moderate Dec 2, 2020

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.
FDA Devices Moderate Apr 27, 2016

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 retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing the urine to drain.
FDA Devices Moderate May 6, 2015

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.
FDA Devices Moderate Nov 5, 2014

Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
FDA Devices Low Nov 5, 2014

Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasio
FDA Devices Moderate Jun 12, 2013

Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture.
FDA Devices Moderate May 29, 2013

Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.

Coloplast Manufacturing US,… holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (28 here).

Apollo Care, LLC 28 Arthrex, Inc. 28 Buick,Chevrolet 28 Dollar General Corporation 28 Healthmaxx Global Inc. 28

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Arthrex, Inc. 28 Universal Meditech Inc. 28 Zimmer Surgical Inc 28 Daye (Anne's Day LTD) 29

Frequently Asked Questions

How many federal recall notices name Coloplast Manufacturing US,…? ▼
PlainRecalls indexes 28 distinct federal recall events naming Coloplast Manufacturing US, LLC, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Coloplast Manufacturing US,… sit among other recalling firms? ▼
Coloplast Manufacturing US, LLC ranks #584 of 14,151 by distinct recall-event count among 14,151 firms in this archive (96th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Coloplast Manufacturing US,…'s notices? ▼
FDA Devices accounts for 28 of this firm's 28 indexed notices.
What product category dominates Coloplast Manufacturing US,…'s filing book? ▼
Filings for Coloplast Manufacturing US, LLC span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Coloplast Manufacturing US, LLC: 28 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Coloplast Manufacturing US, LLC; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026