Olympus Corporation of the Americas: Brand Name: Single Use Electrosurgical Knife Product

Olympus Corporation of the Americas: Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L

Medical DevicesSource: FDA (device) · Date: 2026-02-11

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: Olympus Corporation of the Americas
Product: 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.
Reason / hazard: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Classification: Class II
Status: Ongoing
Distribution / sold at: US Nationwide distribution.
Recall initiated: 2024-02-17
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
Product quantity: units
Voluntary mandated: Voluntary: Firm initiated
City: Center Valley
State: PA
Country: United States
Event id: 98007