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 - DangerousWhat Should You Do?
- 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;
- 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¿ 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.govFDA Recall Number: Z-2509-2025
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