FDA recall Z-1222-2026

Olympus Corporation of the Americas · Class II · device

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 for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-02-17
Report date
2026-02-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1222-2026