Class IIReported 2026-04-01

Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.

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-1641-2026

Classification

Class II

Status

Ongoing