Integra LifeSciences recalls MediHoney Gel dressings with model numbers 31805 and 31815 due to potential packaging failures that could breach the sterile barrier. Affected units include specific serial and lot numbers.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Integra LifeSciences is recalling MediHoney Gel dressings with model numbers 31805 and 31815 because their packaging might fail, risking a breach in the sterile barrier. This could lead to infection if the dressing is used on wounds.
The packaging could fail, breaking the sterile barrier that protects the wound. This might allow bacteria to enter the wound, increasing infection risk.
People using MediHoney Gel dressings for light to moderately exuding wounds. Those with specific serial numbers or lot numbers listed in the recall are most at risk.
Check the model number on the packaging: 31805 or 31815. Look for specific serial numbers (for model 31805) or lot numbers (for model 31815) listed in the recall notice.
Identify the model number and serial/lot numbers to confirm if your MediHoney Gel is affected.
The recall is due to potential packaging failures that could breach the sterile barrier, increasing infection risk.
Model numbers 31805 and 31815 are affected, with specific serial and lot numbers listed in the recall.
Check the model number on the packaging and compare it to the listed serial numbers for model 31805 or lot numbers for model 31815.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1363-2026 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1363-2026 from Integra LifeSciences. 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.