RecallRadar

FDA Device recall Z-2505-2025

Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptos…

On 2025-09-10 the FDA classified a Class II recall of Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptos… by Integra Lifesciences Neurosciences, citing packaging failures were identified which could lead to a breach in the sterile barrier.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2505-2025
ClassificationClass II
Statusongoing
Initiated2025-08-05
Published2025-09-10
Last updated2026-09-13 11:57 UTC
CompanyIntegra Lifesciences Neurosciences
DistributionUS

Product

Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 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.

Identifiers

code_info
Model/Catalog Number: 31505; UDI: 10381780486930; Lot #s: 2150, 2336, 2151, 2337, 2201, 2414, 2209, 2415, 2217, 2417, 2…Model/Catalog Number: 31505; UDI: 10381780486930; Lot #s: 2150, 2336, 2151, 2337, 2201, 2414, 2209, 2415, 2217, 2417, 2232, 2428, 2241, 2434, 2301, 2435, 2312, 2505, 2313, 2508, 2314, 2509, 2328;

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2505-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.