Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620 Recalled by Integra LifeSciences Corp. (NeuroSciences) Due to Packaging failures were identified which could lead to...

Date: August 5, 2025
Company: Integra LifeSciences Corp. (NeuroSciences)
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. (NeuroSciences) directly.

Affected Products

Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 100%, 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.

Quantity: 5374 units

Why Was This Recalled?

Packaging failures were identified which could lead to a breach in the sterile barrier.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Integra LifeSciences Corp. (NeuroSciences)

Integra LifeSciences Corp. (NeuroSciences) has 23 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report