Device recall
Z-2509-2025: Brand Name: MediHoney Product Name: MediHoney Hydrogel Model/Catalog Number…
FDA device recall · Class II · Integra LifeSciences Corp. (NeuroSciences)
Key facts
| Recall number (Z-number) | Z-2509-2025 |
|---|---|
| Recall event | 97404 |
| Product | Brand Name: MediHoney Product Name: MediHoney Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel gelling agent. The gelling… |
| Product code | FRO |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences) |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K110546 |
| 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