Recall Z-2506-2025— Integra LifeSciences Corp. (NeuroSciences)
Class II · Ongoing
Class II FDA medical device recall by Integra LifeSciences Corp. (NeuroSciences), initiated 2025-08-05. It names one FDA 510(k) clearance: K080315. Product: Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. 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.. Reason: Packaging failures were identified which could lead to a breach in the sterile barrier..
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-05
- Firm location
- Princeton, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. 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.
Reason for recall
Packaging failures were identified which could lead to a breach in the sterile barrier.
Data sourced from openFDA. This site is unofficial and independent of the FDA.