Skip to content
Recall Observatory FDA recall evidence

Device 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)

Z-0054-2025

September 13, 2024

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 95397
Status
Ongoing
Classification
Class II
Quantity
120124 units
Official record key
device-enforcement:Z-0054-2025

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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