Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product De
Summary
The FDA issued a Class II for Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/ by Integra LifeSciences Corp. (NeuroSciences). Reason: Packaging failures were identified which could lead to a breach in the sterile barrier..
Details
Source
Device Recall
External ID
Z-2510-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. 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 not require a secondary dressing.
Lot/Code Info: Model/Catalog Numbers: (1) 31722, (2) 31744; UDIs - (1) 10381780471387, (2) 10381780471394; Lot #s: (1) 44422, 14223, (2) 50423, 12523;
Quantity Affected: 1147 units
Reason for Recall
Packaging failures were identified which could lead to a breach in the sterile barrier.
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-05
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Integra LifeSciences Corp. (NeuroSciences) has 30 FDA actions in our database, including 30 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Integra LifeSciences Corp. (NeuroSciences)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integra LifeSciences Corp. (NeuroSciences) have FDA actions?
Integra LifeSciences Corp. (NeuroSciences) has 30 FDA actions in our database, including 30 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2510-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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