Device recall
Z-1168-2025: Brand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-1168-2025 |
|---|---|
| Recall event | 96109 |
| Product | Brand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling agents. The gelling agents… |
| Product code | FRO |
| Recalling firm | Integra LifeSciences Corp. |
| 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