Integra LifeSciences Corp.: Device Recall

Recall #Z-1168-2025 · 01/10/2025

Class II: Risk

Recall Details

Recall Number
Z-1168-2025
Classification
Class II
Product Type
Device
Recalling Firm
Integra LifeSciences Corp.
Status
Ongoing
Date Initiated
01/10/2025
Location
Princeton, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,166 units

Reason for Recall

Potential that the induction seal is not completely sealed to the device tube packaging.

Product Description

Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing upon application. As a percentage of the overall dressing, MediHoney Gel dressing contains 80% medical grade honey by weight. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used. Component: No

Distribution Pattern

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, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY and the Virgin Islands and the country of Malaysia.

Other Recalls by Integra LifeSciences Corp.

View all recalls by Integra LifeSciences Corp. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.