Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog… — Class II medical device recall Z-2506-2025
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-2506-2025 |
|---|---|
| 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 | 141,620 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10381780486824, 10381780486831 |
| Model numbers | 10381780486824, 10381780486831, 2108, 2116, 2123, 2124, 2127, 2128, 2129, 2132, 2133, 2136, 2137, 2138, 2139, 2143, 2150, 2201, 2209, 2210, 2211, 2212, 2213, 2222, 2223 and 16 more |
Product
Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used.
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-2506-2025. 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.