Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0054-2025 — 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)

U.S. FDA — Device Enforcement · United States · 2024-09-13 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0054-2025
Date of alert: 2024-09-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Integra LifeSciences Corp.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10381780486824

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0054-2025 — 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)

Related