Device recall
Z-1363-2026: MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805…
FDA device recall · Class II · Integra LifeSciences Corp. (NeuroSciences)
Key facts
| Recall number (Z-number) | Z-1363-2026 |
|---|---|
| Recall event | 98175 |
| Product | MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds. |
| Product code | FRO |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences) |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K101793 |
| 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