Device recall
Z-1396-2025: CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for…
FDA device recall · Class I · Calyxo, Inc.
Key facts
| Recall number (Z-number) | Z-1396-2025 |
|---|---|
| Recall event | 96340 |
| Product | CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior. |
| Product code | FED |
| Recalling firm | Calyxo, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K233472 |
| FEI number | 3014683069 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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