Device recall
Z-0247-2025: SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-0247-2025 |
|---|---|
| Recall event | 95432 |
| Product | SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery. |
| Product code | HBA |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K193346 |
| FEI number | 3003418325 |
At a glance
- 1–9 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