Olympus Corporation of the Americas recalls Brand Name: Olympus HALO PKS Cutting Forceps

Recalling company

Olympus Corporation of the Americas

Product

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

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Feb 25, 2026

Reported

Apr 1, 2026

Distribution

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

Status

Ongoing

Quantity

2648 units

Lot / codes

Model: HACF0533; UDI: 00821925036390; Lot Numbers: All unexpired;

Company location

Center Valley, PA

Recall type

Voluntary: Firm initiated

Recall number

Z-1641-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1641-2026 in the FDA Enforcement Report. Also see FDA recall press releases.