Coloplast Manufacturing US, LLC recalls
Every recall we track for Coloplast Manufacturing US, LLC — 22 in all, from 2020–2024 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Coloplast Manufacturing US, LLC peaked in 2023 (17); 22 since 2017.
All FDA recall records for Coloplast Manufacturing US, LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 1 | 1 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 3 | 13 | 1 | 17 |
| 2024 | 0 | 0 | 3 | 0 | 3 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Coloplast Manufacturing US, LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Coloplast Manufacturing US, LLC recalls
5 shown- Lower riskMedical device
Coloplast Manufacturing US, LLC recalls X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222,
Coloplast recalls X-Flow prostatectomy catheters with specific device reference numbers and lot numbers due to a possible sterility issue detected in their facility.
ColoplastDec 2, 2024 - Lower riskMedical device
Coloplast Manufacturing US, LLC recalls Ureteral dilator, REF RBD014
Coloplast recalls ureteral dilator products REF RBD014 with possible sterility packaging breaches. Affected units have specific lot codes; contact for remedy.
ColoplastMar 11, 2024 - Lower riskMedical device
Coloplast Manufacturing US, LLC recalls Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
Coloplast recalls Titan Pump Assembly (Catalog 5177701400) due to potential premature pump failure from decreased wall thickness. Affected units include specific lot numbers for inflatable penile prostheses.
ColoplastMar 1, 2023 - Lower riskMedical device
Coloplast Manufacturing US, LLC recalls Torosa Saline-Filled Testicular Prosthesis (Size Small)
Coloplast recalls small saline-filled testicular prosthesis units due to size mislabeling. Affected units may not fit properly, but no injury risk is reported.
ColoplastNov 9, 2021 - UnratedMedical device
Coloplast Manufacturing US, LLC recalls Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are
Coloplast recalls Titan Pump devices for men with erectile dysfunction implants due to potential increased fracture risk over time. No remedy specified in official notice.
ColoplastOct 23, 2020
Coloplast Manufacturing US, LLC recall questions
How many recalls has Coloplast Manufacturing US, LLC had?
22 recalls from Coloplast Manufacturing US, LLC are on record with U.S. safety agencies, from 2020–2024.
What is the most recent Coloplast Manufacturing US, LLC recall?
Coloplast Manufacturing US, LLC recalls X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222,, dated Dec 2, 2024. Every Coloplast Manufacturing US, LLC recall is listed on this page, newest first.
What should I do if I have a recalled Coloplast Manufacturing US, LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Coloplast Manufacturing US, LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.