Coloplast Manufacturing US, LLC
FDA Regulatory Profile
Coloplast Manufacturing US, LLC appears in FDA public data with 28 recalls, 4 510(k) clearances, 13 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0845-2025, Class II) was initiated on December 2, 2024. Its most recent 510(k) clearance was granted on May 26, 2010.
Summary
- Total Recalls
- 28
- 510(k) Clearances
- 4
- Inspections
- 13
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0845-2025 | Class II | X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB61 | December 2, 2024 |
| Z-0844-2025 | Class II | Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, A | December 2, 2024 |
| Z-1463-2024 | Class II | Ureteral dilator, REF RBD014 | March 11, 2024 |
| Z-1364-2023 | Class II | Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1368-2023 | Class II | Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1359-2023 | Class II | Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1375-2023 | Class II | Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1373-2023 | Class II | Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1369-2023 | Class II | Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1361-2023 | Class II | Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1365-2023 | Class II | Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1374-2023 | Class II | Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1363-2023 | Class II | Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1366-2023 | Class II | Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1372-2023 | Class II | Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1362-2023 | Class II | Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1370-2023 | Class II | Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1371-2023 | Class II | Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1367-2023 | Class II | Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis | March 1, 2023 |
| Z-1360-2023 | Class II | Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis | March 1, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K100878 | SELF CATH CATHETER | May 26, 2010 |
| K093112 | DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX | February 1, 2010 |
| K082640 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM | October 17, 2008 |
| K070939 | SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM | June 1, 2007 |