Device recall
Z-1364-2026: MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1)…
FDA device recall · Class II · Integra LifeSciences Corp. (NeuroSciences)
Key facts
| Recall number (Z-number) | Z-1364-2026 |
|---|---|
| Recall event | 98175 |
| Product | MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds |
| Product code | FRO |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences) |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K053095 |
| 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