United StatesOlympus Single Use Electrosurgical Knife models KD-640L (KD640-L, UDI 04953170208423) and KD-645L (KD-645L, UDI 04953170407857) — monopolar electrosurgical knives used for endoscopic cutting/coagulation — are subject to a recall. The devices were recalled because deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use; the recall affects 3,361 units distributed nationwide in the United States and specific lot numbers are identified in the FDA notice.
What's being recalled
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.
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.
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA, United States.
How to identify it
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 Model/Catalog Number: KD-645L UDI: 04953170407857 Lot Number(s): 2ZK, 31K, 32K, 33K, 35K, 3XK, 3YK, 3ZK, 42K, 43K, 44K, 45K, 46K, 47K, 48K, 49K, 4XK, 4YK, 4ZK, 51K, 52K, 53K, 54K, 55K, 56K, 57K, 58K, 59K
The hazard
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)