Olympus recalls Gyrus Acm: PKS Omni 5mm/33cm surgical tools due to expired adhesive causing potential tissue burns. Affected units sold with Gyrus ACMI G400 workstation.
Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.
Olympus recalls Gyrus Acmi PKS Omni 5mm/33cm surgical tools that could cause tissue burns if the expired adhesive fails. This hazard affects devices used with the Gyrus ACMI G400 workstation.
The adhesive used for electrical insulation and retention has expired. When it fails, it can cause electrical contact with the patient's tissues, leading to burns in critical areas.
Surgical teams using the Gyrus Acmi PKS Omni 5mm/33cm tools with the Gyrus ACMI G400 workstation are most at risk. Patients undergoing surgery with these tools may experience tissue burns.
Check for the product name 'Gyrus Acmi PKS Omni 5mm/33cm' and lot number KR121617. The tools were sold with the Gyrus ACMI G400 workstation.
Identify the product name and lot number to confirm if your device is affected.
The expired adhesive used as electrical insulation and retention could fail, causing tissue burns.
The recall record does not specify a remedy, so contact Olympus for guidance.
The hazard could cause tissue burns, but the recall record does not specify if this risk occurs in normal use.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2380-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2380-2021 from Olympus. 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.
