Olympus recalls KD-612U electrosurgical snare models with inadequate sterile package seals, which may lead to infections if non-sterile equipment is used during procedures.
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 certain KD-612U electrosurgical snare models due to a small percentage having poorly sealed sterile packages. This could lead to infections if the equipment is used without proper sterility.
The sterile packages may have inadequate seals, allowing contamination. If non-sterile equipment is used during procedures, patients could develop infections.
Healthcare professionals using the KD-612U electrosurgical snare for procedures in the upper digestive tract. Patients at risk if the snare is used without proper sterility.
The product is labeled as KD-612U electrosurgical snare. It was sold with model numbers 01K through 9ZK. The recall applies to specific packaging versions.
Inspect the sterile package for adequate sealing; if the seal appears damaged or incomplete, do not use the device.
The recall indicates a small percentage of packages have inadequate seals, so it is not safe to use without checking the seal first.
Look for the model number on the packaging, which includes 01K through 9ZK. Check for proper sealing of the sterile package.
Inspect the package seal; if it appears damaged or incomplete, do not use the device. Contact Olympus for further guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0976-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0976-2021 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.
