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.
- Recall Initiated
- February 17, 2024
- Posted
- January 30, 2026
- Recall Number
- Z-1222-2026
- Quantity
- units
- Firm Location
- Center Valley, PA
Reason for Recall
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Distribution
US Nationwide distribution.
Lot / Code Info
Model/Catalog Number: KD640-L UDI: 04953170208423 Lot Number(s): 2ZK, 31K, 32K, 33K, 34K, 35K, 36K, 37K, 38K, 39K, 3XK, 3YK, 3ZK, 41K, 42K, 43K, 44K, 45K, 46K, 47K, 48K, 49K, 4XK, 4YK, 4ZK, 51K, 52K, 53K, 54K, 55K, 58K, 59K
Root Cause
Device Design
Action Taken
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.