Olympus Corporation Of The Americas recalls Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use E…

A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

On December 17, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Carefully read the content of this notification. 2. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, including the instruction for intermittent output activation and applicable Warnings and Cautions. 3. Keep a copy of this notification with the Instructions for Use for any affected devices remaining in your inventory. 4. If you have further distributed the affected product, please identify your customers and forward this notification to them. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail Cynthia.Ow@Olympus.com.

• FDA enforcement recordOfficial FDA database entry for Z-1223-2026
• FDA 510(k) clearance · K182408The device's official FDA premarket clearance record
• FDA device classification · KNSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.4300The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.