MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHo
Pending LLM rewrite. Source: FDA_DEVICE Z-1363-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Potential packaging failures, which could lead to a breach in the sterile barrier.
The recalled product
- 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.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- 2425
Distribution
Distributed nationwide across the United States.
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