FDA DeviceClass IINotable

FDA Recall: Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/C

Name: FDA Recall: Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/C
Brand: Olympus Corporation of the Americas

Date: 2026-04-01

Brand: Olympus Corporation of the Americas

Category: Medical Device

FDA Class: Class II

Description

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.