Device recall
Z-0312-2025: microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use…
FDA device recall · Class I · FHC, Inc.
Key facts
| Recall number (Z-number) | Z-0312-2025 |
|---|---|
| Recall event | 95479 |
| Product | microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures. |
| Product code | HAW |
| Recalling firm | FHC, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K011775 |
| FEI number | 3002250546 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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