Recall Z-1168-2025— Integra LifeSciences Corp.

Name: FDA recall Z-1168-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-10

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2025-01-10. It names one FDA 510(k) clearance: K101793. Product: 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. Reason: Potential that the induction seal is not completely sealed to the device tube packaging..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Ongoing
Initiated: 2025-01-10
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K101793 — MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEYDerma Sciences, Inc.·cleared 2011-02-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.