Integra LifeSciences recalls MediHoney Hydrogel dressings (models 31620, 31640) due to packaging failures that could breach the sterile barrier. Affected units include specific lot numbers and serials.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Integra LifeSciences is recalling MediHoney Hydrogel dressings (models 31620 and 31640) because packaging failures might compromise the sterile barrier. This could lead to infection risks for wound patients using the product.
The packaging failures could allow contamination of the sterile dressing, potentially leading to infection. MediHoney is a non-adhesive hydrogel dressing that uses honey to maintain a moist wound environment.
Patients using MediHoney Hydrogel dressings for wound care are most at risk if the sterile barrier is compromised. The recall affects specific lot numbers and model numbers sold through medical suppliers.
Check for model numbers 31620 or 31640 on the packaging. Affected units include specific lot numbers listed in the recall notice.
Identify the model number on the MediHoney Hydrogel dressing packaging (31620 or 31640).
Confirm the lot numbers match those listed in the recall notice (e.g., 30623, 40724, etc.).
The recall indicates packaging failures could breach the sterile barrier, but the product is safe if the packaging remains intact. Affected units should be checked.
Check the model and lot numbers against the recall list. If affected, contact Integra LifeSciences for guidance.
The recall does not specify a replacement process; contact Integra LifeSciences directly for assistance.
We’ve drafted a message you can send MediHoney to request your refund or repair — edit it as you like.
Subject: Recall Z-2509-2025 — MediHoney MediHoney Hello, I own a MediHoney that is covered by recall Z-2509-2025 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.
