Z-1640-2026 Class II Ongoing
FDA device recall Z-1640-2026 was initiated by Olympus Corporation of the Americas on February 25, 2026 and is designated Class II. 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 d… The recall status is ongoing. Affected quantity: 444 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2026
- Initiation Date
- February 25, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 444 units
Product Description
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 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.
Distribution Pattern
Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
Code Information
Model: PK-CF0533; UDI: 00821925035867; Lot Numbers: All unexpired;