Olympus recalls KD-612L electrosurgical knives with inadequate sterile package seals that could lead to patient infections if non-sterile equipment is used. Affected units were sold in specific model series.
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Olympus is recalling some KD-612L electrosurgical knives because their sterile packaging may have poor seals, increasing infection risk during surgery. This is serious because surgical equipment must be sterile to prevent infections.
The sterile packaging for these knives may have partial heat seals, meaning the packaging isn't fully airtight. If the packaging isn't sealed properly, the knives could become contaminated, leading to infections during surgery.
Surgical teams and hospitals using the KD-612L model knives for endoscopic procedures are most at risk. Patients could develop infections if non-sterile equipment is used during surgery.
Check for the model number KD-612L on the knife. Affected units were sold with specific model series codes like 01K through 9ZK in the past.
Inspect the packaging for partial heat seals that may allow contamination.
Inspection confirmed a small percentage of sterile packages have inadequate seals, which could lead to infections if non-sterile equipment is used during surgery.
Look for the model number KD-612L on the knife. Affected units were sold with specific model series codes like 01K through 9ZK.
Check the packaging for partial heat seals. If you find a seal issue, contact Olympus for guidance on next steps.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0975-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0975-2021 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.
