CanadaOlympus single-use electrosurgical knives identified by catalogue numbers KD-640L (Upper Digestive Tract) and KD-645L, with lot or serial numbers consisting of more than 10 digits, are affected. They were recalled because deterioration of the cutting knife from overheating and burning can contribute to tip breakage during use; Olympus is also updating the instructions for use and labeling. Contact the manufacturer if you require additional information.
What's being recalled
This recall is linked to the previous recall action, RA-75283 with recall start date of March 6, 2024. See this link for more information: https://recalls-rappels.canada.ca/en/alert-recall/olympus-medical-single-use-electrosurgical-knives
Companies: Olympus Medical Systems Corp., 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507.
How to identify it
Affected products: Single Use Electrosurgical Knife - Upper Digestive Tract; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-640L
Affected products: Single Use Electrosurgical Knife KD-645; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-645L
The hazard
Olympus determined that deterioration of the cutting knife, caused by overheating and burning, can contribute to tip breakage during use. Olympus is also notifying users of the updates to the instructions for use and labeling.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)