Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn… — Class II medical device recall Z-1168-2025
Ongoing recall by Integra LifeSciences Corp., reported 2025-02-19, distributed nationwide. Potential that the induction seal is not completely sealed to the device tube packaging.
| Recall number | Z-1168-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2025-01-10 |
| Classified | 2025-02-12 |
| Reported by FDA | 2025-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | MY |
| Quantity | 12,166 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10381780486886 |
| Lot numbers | 2328, 2332, 2333 |
| Model numbers | 31815 |
Product
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing upon application. As a percentage of the overall dressing, MediHoney Gel dressing contains 80% medical grade honey by weight. 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. Component: No
Reason for recall
Potential that the induction seal is not completely sealed to the device tube packaging.
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-1168-2025. 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.