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
    • 31612
    • 31622
    • 31644
  • 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) 10381780471363
    • lot#s: (1) D034323
    • (2) 50623
    • 45022
    • 34023
    • (3) 41223
    • 50423
    • 10323
    • 54223
    • 42323
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.