Recall Z-0054-2025— Integra LifeSciences Corp.

Name: FDA recall Z-0054-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-13

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2024-09-13. It names one FDA 510(k) clearance: K080315. Product: MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535). Reason: There is a potential for pinholes in the applicator pouch film which creates a sterility concern..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Ongoing
Initiated: 2024-09-13
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K080315 — DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEYDerma Sciences, Inc.·cleared 2008-04-23

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

MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)

Reason for recall

There is a potential for pinholes in the applicator pouch film which creates a sterility concern.

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