Device recall
Z-2909-2026: Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
FDA device recall · Class II · Freudenberg Medical, LLC
Key facts
| Recall number (Z-number) | Z-2909-2026 |
|---|---|
| Recall event | 99299 |
| Product | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF |
| Product code | EWL |
| Recalling firm | Freudenberg Medical, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K932120 |
| FEI number | 2025182 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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