Z-0054-2025 Class II Ongoing
FDA device recall Z-0054-2025 was initiated by Integra LifeSciences Corp. on Sep 13, 2024 and is designated Class II. Reason for recall: There is a potential for pinholes in the applicator pouch film which creates a sterility concern. The recall status is ongoing. Affected quantity: 120124 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 16, 2024
- Initiation Date
- Sep 13, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120124 units
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.
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.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0054-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026