Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing… — Class II medical device recall Z-2507-2025
Ongoing recall by Integra LifeSciences Corp. (NeuroSciences), reported 2025-09-10, distributed nationwide. Packaging failures were identified which could lead to a breach in the sterile barrier.
| Recall number | Z-2507-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States |
| Recall initiated | 2025-08-05 |
| Classified | 2025-09-03 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, KR, MY, NZ |
| Quantity | 3,583 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10381780471356, 10381780471363, 10381780486947 |
| Model numbers | 31612, 31622, 31644 |
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel collodial gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does require a secondary dressing.
Reason for recall
Packaging failures were identified which could lead to a breach in the sterile barrier.
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-2507-2025. 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.