Device recall
Z-1359-2023: Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
FDA device recall · Class II · Coloplast Manufacturing US, LLC
Key facts
| Recall number (Z-number) | Z-1359-2023 |
|---|---|
| Recall event | 91800 |
| Product | Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis |
| Product code | FHW |
| Recalling firm | Coloplast Manufacturing US, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P000006 |
| FEI number | 2125050 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database