Olympus recalls KD-650U 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 its KD-650U electrosurgical snare devices due to a small percentage having inadequate sterile package seals. This could lead to infections if the equipment is used without proper sterility.
The sterile packages for these devices can have partial heat seals, meaning they might not be properly sealed. If the equipment is not sterile, it could lead to infections during medical procedures.
Healthcare professionals using the KD-650U electrosurgical snare for procedures in the upper digestive tract. Patients at risk are those who may have been exposed to non-sterile equipment during surgery.
Check for the model number KD-650U on the device. The product was sold with serial codes starting with 01K through 9ZK.
Inspect the sterile package for signs of partial heat sealing, which may indicate inadequate sterility.
The recall indicates a small percentage of units have inadequate package seals, so they may not be sterile. Do not use if you suspect the seal is compromised.
Look for the model number KD-650U and serial codes starting with 01K through 9ZK on the device.
Inspect the package seal for partial heat sealing. If the seal appears compromised, do not use the device and 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-0981-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0981-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
