Device recall
Z-1170-2025: Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device…
FDA device recall · Class II · Hologic, Inc
Key facts
| Recall number (Z-number) | Z-1170-2025 |
|---|---|
| Recall event | 96075 |
| Product | Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A |
| Product code | KNW |
| Recalling firm | Hologic, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K150169 |
| FEI number | 1000120743 |
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