[pending] MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHo
Pending LLM rewrite. Source: FDA_DEVICE Z-1363-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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