Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Class II

Recalling firm: Olympus Corporation of the Americas
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.
Affected products (lot / model / serial): Model: 920000PK; UDI: 00821925038080; Lot Numbers: All unexpired;
Units affected: 7 units
Distribution pattern: Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
Firm location: Center Valley, PA, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-1643-2026
Recall initiated: February 25, 2026
FDA classification date: March 25, 2026
FDA report date: April 1, 2026
FDA event ID: 98454
Last updated on HTM Vibe: July 24, 2026