FDA DeviceClass IINotable

FDA Recall: Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Mode

Name: FDA Recall: Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Mode
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.