Integra LifeSciences recalls MEDIHONEY Calcium Alginate with Leptospermum Honey (models 31012, 31022, 31045) due to potential packaging failures that could breach the sterile barrier. Affected units include specific lot numbers and model numbers listed in the recall notice.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Integra LifeSciences is recalling MEDIHONEY Calcium Alginate Dressing with active Leptospermum Honey because its packaging might fail, risking a breach in the sterile barrier. This could expose wounds to contaminants during use, especially for people with open wounds needing this dressing.
The packaging might fail, creating a breach in the sterile barrier that could expose wounds to contaminants. This is a risk during use when the dressing is applied to open wounds, potentially leading to infection.
People who own or use MEDIHONEY Calcium Alginate Dressing with active Leptospermum Honey (models 31012, 31022, 31045) are affected. Those with open wounds requiring this dressing are most at risk due to potential contamination.
Check for model numbers 31012, 31022, or 31045 on the product packaging. Also look for specific lot numbers listed in the recall notice for each model.
Identify the model number (31012, 31022, or 31045) on the product packaging to confirm if it is affected.
Reach out to Integra LifeSciences for specific instructions on how to handle affected units, as the recall remedy is not stated in the record.
The recall states potential packaging failures could breach the sterile barrier, but no specific remedy is provided. Affected units should be checked for model numbers and lot numbers listed in the recall notice.
The recall record does not specify a remedy, so contact Integra LifeSciences directly for guidance on handling affected units.
Model numbers 31012, 31022, and 31045 are affected, with specific lot numbers listed for each model in the recall notice.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1364-2026 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1364-2026 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.
