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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Model/Catalog Number: (1) 31620, (2) 31640; UDIs: (1) 10381780471370, (2) 10381780471400; Lot#s: (1) 30623, 40724, 25022, 23823, 54922, 24123, 54322, 54023, 23024, 43823, 13424, (2) 24423, 53424, 11323, 51324, 10823, 20224, 30823, 24623, 33524, 34523;
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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¿ 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.

Product Codes/Lot Numbers:

Model/Catalog Number: (1) 31620, (2) 31640; UDIs: (1) 10381780471370, (2) 10381780471400; Lot#s: (1) 30623, 40724, 25022, 23823, 54922, 24123, 54322, 54023, 23024, 43823, 13424, (2) 24423, 53424, 11323, 51324, 10823, 20224, 30823, 24623, 33524, 34523;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2509-2025

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