Olympus Corporation of the Americas recalls Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HAC…

Recall date

February 25, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1641-2026

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.