Olympus recalls KD-640L 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-640L electrosurgical snare models due to a risk of infection from poorly sealed sterile packages. Using non-sterile equipment during procedures could expose patients to infections.
The sterile packages may have inadequate seals, allowing contaminants to enter. If non-sterile equipment is used during procedures, patients could develop infections.
Healthcare professionals using the KD-640L electrosurgical snare models for endoscopic procedures are most at risk of patient infections if the sterile packages are compromised.
Check for the model number KD-640L on the product. The product was sold with model suffixes 01K through 07K, 09K, 0XK, 98K, 99K, 9XK, 9YK, and 9ZK.
Inspect the sterile package for adequate sealing; if the seal appears damaged or incomplete, do not use the product.
The product may be safe if the sterile package seal is intact. However, if the seal is inadequate, using it could lead to infections.
Look for the model number KD-640L with suffixes 01K through 07K, 09K, 0XK, 98K, 99K, 9XK, 9YK, or 9ZK on the product.
Inspect the sterile package seal; if it appears damaged or incomplete, do not use the product. 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-0979-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0979-2021 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.
