Medical Device Recall: Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consis
Olympus Corporation of the Americas · February 17, 2024
Reason for Recall
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Product Description
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L 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.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
3361 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1223-2026
Status: ongoing
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