# FDA recall Z-2507-2025

> **Integra LifeSciences Corp. (NeuroSciences)** · Class II · device recall initiated 2025-08-05.

## Product

Brand Name: MediHoney¿  Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum  Model/Catalog Number: 31612, 31622, 31644  Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel collodial gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing   which has a low pH and high osmolarity   forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does require a secondary dressing.

## Reason for recall

Packaging failures were identified which could lead to a breach in the sterile barrier.

## 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, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.

## Key facts

- **Recall number:** Z-2507-2025
- **Recalling firm:** Integra LifeSciences Corp. (NeuroSciences)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-05
- **Report date:** 2025-09-10

- **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-2507-2025

## Citation

> AI Analytics. FDA recall Z-2507-2025. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-2507-2025. Source: US FDA. Licensed CC0.

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