Device recall
Z-1467-2025: Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint…
FDA device recall · Class II · Checkpoint Surgical Inc
Key facts
| Recall number (Z-number) | Z-1467-2025 |
|---|---|
| Recall event | 96387 |
| Product | Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing stimulus to a targeted… |
| Product code | ETN |
| Recalling firm | Checkpoint Surgical Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K212355 |
| FEI number | 3012222873 |
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