FDAClass IISeptember 10, 2025

Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS recall: Sterility Concern

Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL…

Why was Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model/Catalog Number: 31738; UDI- 10381780486961; Lot # 53824;

Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL…
Recalling firm
Integra LifeSciences Corp. (NeuroSciences)
Quantity
4 units
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.
Recall date
September 10, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls