Olympus Corporation of the Americas: Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description

Hazard

A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Details from the source

Reason for recall: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use. Distribution: US Nationwide distribution. Quantity: 3361 units Lot/code info: 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

UPC codes

04953170407857

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.