MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn… — Class II medical device recall Z-0054-2025
Ongoing recall by Integra LifeSciences Corp., reported 2024-10-16, distributed nationwide. There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
| Recall number | Z-0054-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2024-09-13 |
| Classified | 2024-10-10 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | MY |
| Quantity | 120,124 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10381780486824, 10381780486831 |
| Model numbers | 31515, 31535 |
| Expiration dates | 2024-08-01 |
Product
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)
Reason for recall
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0054-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.