Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ 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.

Class I - Dangerous

🏥 Medical Devices Recalled: August 5, 2025 Integra LifeSciences Corp. (NeuroSciences) Infusion Pumps Nationwide

What Should You Do?

Check if you have this product:
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;
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Integra LifeSciences Corp. (NeuroSciences)
Reason for Recall:: Packaging failures were identified which could lead to a breach in the sterile barrier.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ 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.

Product Codes/Lot Numbers:

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;