Olympus Corporation of the Americas recalls Brand Name: Olympus PK Cutting Forceps

Recalling company

Olympus Corporation of the Americas

Product

Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.

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

444 units

Lot / codes

Model: PK-CF0533; UDI: 00821925035867; Lot Numbers: All unexpired;

Company location

Center Valley, PA

Recall type

Voluntary: Firm initiated

Recall number

Z-1640-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1640-2026 in the FDA Enforcement Report. Also see FDA recall press releases.