FDA Device recall Z-1363-2026
MediHoney Gel with Active Leptospermum Honey
- FDA Device
- Class II
- ongoing
- Published 2026-02-25
On 2026-02-25 the FDA classified a Class II recall of MediHoney Gel with Active Leptospermum Honey by Integra Lifesciences Neurosciences, citing potential packaging failures, which could lead to a breach in the sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1363-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-16 |
| Published | 2026-02-25 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Integra Lifesciences Neurosciences |
| Distribution | US |
Product
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds.
Reason
Potential packaging failures, which could lead to a breach in the sterile barrier.
Identifiers
| code_info | 1. Model Number: 31805; UDI-DI: 10381780486978; Serial numbers: 2405, 2406, 2407, 2408, 2409, 2410, 2418, 2419, 2421, 2…1. Model Number: 31805; UDI-DI: 10381780486978; Serial numbers: 2405, 2406, 2407, 2408, 2409, 2410, 2418, 2419, 2421, 2422, 2432, 2433, 2513, 2514, 2515. 2. Model Numbers: 31815; UDI-DI: 10381780486886; Lot Numbers: 2407, 2408, 2419, 2425, 2429, 2430, 2442, 2443, 2444, 2445, 2446, 2449, 2450, 2502, 2513, 2515, 2516. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1363-2026%22
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