Device recall
Z-0328-2025: BioZorb Marker. Radiographic soft tissue marker.
FDA device recall · Class I · Hologic, Inc
Key facts
| Recall number (Z-number) | Z-0328-2025 |
|---|---|
| Recall event | 95639 |
| Product | BioZorb Marker. Radiographic soft tissue marker. |
| Product code | NEU |
| Recalling firm | Hologic, Inc |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K143484, K152070 |
| FEI number | 1000120743 |
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