Class IIReported 2026-04-01

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Reason for Recall

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process

Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Recall Number

Z-1642-2026

Classification

Class II

Status

Ongoing