# FDA recall Z-1168-2025

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2025-01-10.

## Product

Brand Name: MediHoney¿ Gel  Product Name: MediHoney¿ Wound & Burn Dressing Gel  Model/Catalog Number: 31815  Software Version: N/A  Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing upon application. As a percentage of the overall dressing, MediHoney Gel dressing contains 80% medical grade honey by weight. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used.  Component: No

## Reason for recall

Potential that the induction seal is not completely sealed to the device tube packaging.

## Distribution

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

## Key facts

- **Recall number:** Z-1168-2025
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-10
- **Report date:** 2025-02-19

- **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-1168-2025

## Citation

> AI Analytics. FDA recall Z-1168-2025. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1168-2025. Source: US FDA. Licensed CC0.

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