Drug recall
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model…
FDA recall event 95397 · Class II · Integra LifeSciences Corp.
Key facts
| Event ID | 95397 |
|---|---|
| Recall numbers | Z-0054-2025 |
| Recalling firm | Integra LifeSciences Corp. |
| Product type | Devices |
| Products | 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) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for pinholes in the applicator pouch film which creates a sterility concern. |
| Initiation date | Sep 13, 2024 |
| Report date | Oct 16, 2024 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3003418325 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: