# FDA recall Z-0054-2025

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2024-09-13.

## 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 for recall

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

## Distribution

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.

## Key facts

- **Recall number:** Z-0054-2025
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-13
- **Report date:** 2024-10-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0054-2025

## Citation

> AI Analytics. FDA recall Z-0054-2025. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-0054-2025. Source: US FDA. Licensed CC0.

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