Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog...

FDA Device Recall #Z-1640-2026 — Class II — February 25, 2026

Recall Summary

Recall Number Z-1640-2026
Classification Class II — Moderate risk
Date Initiated February 25, 2026
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Olympus Corporation of the Americas
Location Center Valley, PA
Product Type Devices
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.

Lot / Code Information

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

Other Recalls from Olympus Corporation of the Americas

Recall # Classification Product Date
Z-1641-2026 Class II Brand Name: Olympus HALO PKS Cutting Forceps, 5... Feb 25, 2026
Z-1639-2026 Class II Brand Name: Olympus Everest Bipolar Cutting For... Feb 25, 2026
Z-1642-2026 Class II Brand Name: Olympus PKS Cutting Forceps, 5mm 33... Feb 25, 2026
Z-1644-2026 Class II Brand Name: Olympus PKS Cutting Forceps, 5mm 33... Feb 25, 2026
Z-1643-2026 Class II Brand Name: Olympus PKS Cutting Forceps w/Cord,... Feb 25, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.