FDA Device recall Z-2511-2025
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS…
- FDA Device
- Class II
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class II recall of Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS… by Integra Lifesciences Neurosciences, citing packaging failures were identified which could lead to a breach in the sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2511-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-05 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Integra Lifesciences Neurosciences |
| Distribution | US |
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. 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 and supports autolytic debridement, and allows for non-traumatic removal. The product is an occlusive dressing, and does not require a secondary dressing.
Reason
Packaging failures were identified which could lead to a breach in the sterile barrier.
Identifiers
| code_info | Model/Catalog Number: 31738; UDI- 10381780486961; Lot # 53824; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2511-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.