Device recall
Z-0054-2025: MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-0054-2025 |
|---|---|
| Recall event | 95397 |
| Product | MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535) |
| Product code | FRO |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K080315 |
| FEI number | 3003418325 |
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