Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
FDA Recall Z-1222-2026 · Posted 2026-01-30
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Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeKNS
Date Initiated2024-02-17
Product Quantityunits
Reason for Recall
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Firm Action
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 [email protected].
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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