Olympus recalls KD-655U 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 some KD-655U electrosurgical snare devices because their sterile packaging may not seal properly. This could lead to infections if the equipment is used without being properly sterilized.
The sterile packages for these devices may have partial heat seals, meaning they are not fully sealed. If the equipment is not properly sterilized, it could lead to infections during medical procedures.
Healthcare professionals using the KD-655U electrosurgical snare for procedures in the upper digestive tract. Patients at risk are those who receive surgery using the recalled model without proper sterilization.
Check for the model number KD-655U 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 sealing.
The recall indicates a small percentage of packages may have inadequate seals, so it is not safe to assume the product is always sterile. Always check the package seal before use.
The official recall does not specify a remedy, so contact Olympus directly for guidance on whether to use or discard the product.
Look for the model number KD-655U and serial codes starting with 01K through 9ZK on the device.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0983-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0983-2021 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.
