FDAFDA · Food and drugs·Recall number Z-0054-2025
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)
Published October 16, 2024 · Recall initiated: September 13, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp.
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.