Olympus recalls KD-620LR electrosurgical snare models with inadequate sterile package seals, potentially causing infections if non-sterile equipment is used. Affected units sold in specific regions and model numbers.
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-620LR electrosurgical snare devices because their sterile packaging may have poor seals. This could lead to infections if the equipment is used without proper sterility.
The sterile packages for these devices may have inadequate seals due to partial heat sealing. If the seal is compromised, the equipment might not be sterile, increasing the risk of infections during medical procedures.
Healthcare professionals using the KD-620LR electrosurgical snare for digestive procedures are most at risk. Patients could develop infections if non-sterile equipment is used during surgery.
Check for the model number KD-620LR on the device. The product was sold in specific regions with model numbers listed as 01K through 9ZK.
Inspect the sterile packaging for signs of inadequate sealing, such as gaps or improper closure.
The recall states that a small percentage of sterile packages have inadequate seals, which could lead to infections if non-sterile equipment is used. Not all units are affected.
Look for the model number KD-620LR on the device. The product was sold in specific regions with model numbers listed as 01K through 9ZK.
The recall does not specify a remedy, so you should check the package seal for adequate sterility. If you have concerns, contact Olympus directly.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0977-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0977-2021 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.
