Integra LifeSciences recalls MEDIHONEY Dressing with Active Leptospermum Honey wound and burn dressings (Model 31515/31535) due to potential pinholes in the applicator pouch film that could compromise sterility.
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
Integra LifeSciences is recalling MEDIHONEY wound and burn dressings with active Leptospermum honey because the applicator pouch film might have pinholes, creating a sterility risk. This could lead to infection if the dressing is used without proper sterility.
The applicator pouch film may develop pinholes during manufacturing, which could allow contaminants to enter the dressing. This poses a sterility risk if the dressing is used on open wounds or burns without proper cleaning.
People who own or use the MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR (Model 31515 or 31535) are affected. Those with open wounds or burns are at slightly higher risk due to the sterility concern.
Check for the model numbers 31515 (1.5oz) or 31535 (3.5oz) on the packaging. The product was sold from December 17, 2020, to July 22, 2024, with expiration dates from August 1, 2024, to June 1, 2028.
Look for model numbers 31515 or 31535 on the packaging to confirm if the product is recalled.
The recall is due to a potential sterility risk from pinholes in the applicator pouch film, so it is not recommended for use until the recall is addressed.
The recall does not specify a remedy, so you should check the product details to confirm if it is recalled and contact Integra LifeSciences for further instructions.
Check for model numbers 31515 (1.5oz) or 31535 (3.5oz) on the packaging. The product was sold from December 17, 2020, to July 22, 2024.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0054-2025 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0054-2025 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.
