Olympus Corporation of the Americas: Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Pro

Olympus Corporation of the Americas: Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An

Medical DevicesSource: FDA (device) · Date: 2026-04-01

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: 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 / hazard: 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
Status: Ongoing
Distribution / sold at: Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
Recall initiated: 2026-02-25
Code info: Model: PK-CF0533; UDI: 00821925035867; Lot Numbers: All unexpired;
Product quantity: 444 units
Voluntary mandated: Voluntary: Firm initiated
City: Center Valley
State: PA
Country: United States
Event id: 98454