Integra LifeSciences recalls MediHoney HCS Sheet Dressing with Leptospermum (model 31612, 31622, 31644) due to packaging failures that could breach the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Integra LifeSciences is recalling MediHoney HCS Sheet Dressing with Leptospermum because packaging failures might break the sterile barrier. This could expose the dressing to contaminants, risking infection during wound care.
The dressing's packaging could fail, leading to a breach in the sterile barrier. This might expose the dressing to contaminants, increasing infection risk during wound healing.
Patients using MediHoney HCS Sheet Dressing with Leptospermum for wound care are affected. Those with open wounds or recent injuries are most at risk.
Check for model numbers 31612, 31622, or 31644 on the MediHoney HCS Sheet Dressing with Leptospermum packaging. The product was sold with specific lot numbers and unique identifiers.
Look for model numbers 31612, 31622, or 31644 on the product packaging.
Packaging failures could lead to a breach in the sterile barrier, increasing infection risk during wound care.
Models 31612, 31622, and 31644 of MediHoney HCS Sheet Dressing with Leptospermum.
The recall record does not specify a remedy.
We’ve drafted a message you can send MediHoney to request your refund or repair — edit it as you like.
Subject: Recall Z-2507-2025 — MediHoney MediHoney Hello, I own a MediHoney that is covered by recall Z-2507-2025 from MediHoney. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
