Reported Sep 10, 2025 · Ongoing
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612,…
Integra LifeSciences Corp. (NeuroSciences)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. (NeuroSciences) · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
- Brand NameMediHoney¿
- Product NameMediHoney¿ HCS Sheet Dressing
- with Leptospermum Model/Catalog Number
316123162231644
- Product DescriptionMEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel collodial gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. 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 in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does require a secondary dressing
- Lot codes and dates
- Model/Catalog Number
(1) 31612(2) 31622(3) 31644
- UDIs
(1) 10381780486947(2) 10381780471356(3) 10381780471363lot#s: (1) D034323(2) 506234502234023(3) 4122350423103235422342323
- Model/Catalog Number
- Amount recalled
- 3583 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Packaging failures were identified which could lead to a breach in the sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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