Olympus recalls KD-620UR electrosurgical snare models with inadequate sterile package seals, which could 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-620UR 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 partial heat seals, meaning they are not properly sealed. If the equipment is used without being sterile, patients could develop infections during medical procedures.
Healthcare professionals using the KD-620UR electrosurgical snare models for procedures involving the upper digestive tract. Patients at risk if non-sterile equipment is used during surgery.
Check for the model number KD-620UR on the product. The product was sold with model suffixes 01K through 9ZK, including 98K, 99K, 9XK, 9YK, and 9ZK.
Inspect the sterile package for partial heat seals; if the seal appears broken or loose, do not use the product.
The recall indicates a small percentage of packages have inadequate seals, so it is not safe to use without checking the seal.
Look for the model number KD-620UR with suffixes 01K through 9ZK, including 98K, 99K, 9XK, 9YK, and 9ZK.
Inspect the package seal; if it appears broken or loose, do not use it. Contact Olympus for further instructions.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0978-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0978-2021 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.
