Integra LifeSciences Corp.: Medical Device Recall in 2024 - (Recall #: Z-0054-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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)

Product Classification:

Class II

Date Initiated: September 13, 2024

Date Posted: October 16, 2024

Recall Number: Z-0054-2025

Event ID: 95397

Reason for Recall:

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

Status: Ongoing

Product Quantity: 120124 units

Code Information:

Model 31515 UDI-DI: 10381780486824; Model 31535 UDI-DI: 10381780486831; All lots distributed from 12/17/2020 to 07/22/2024 with expiration dates 08/01/2024 to 06/01/2028.

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of MN, IL, UT, FL, NC, CA, MO, IN, MS, OH, PA, TX, HI, MA, WA, GA, AZ, VA, NY, CO, MI, OK, NV, NJ, SC, OR, VT, DC, WI, TN, WV, KS, AL, NE, MD, ID, LA, AR, KY, IA, AK, NM, ME, RI and the countries of Madagascar, Malaysia, Guam.

Voluntary or Mandated:

Voluntary: Firm initiated