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.
Recall
- Recall Number
- Z-1640-2026
- Event Number
- 98454
- Firm
- Olympus Corporation of the Americas
- FEI Number
- 2429304
- Product Code
- GEI
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 25, 2026
- Posted
- March 25, 2026
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229
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.
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.
On February 25, 2026 URGENT: MEDICAL DEVICE REMOVAL letters were sent to customers. Actions to be taken: 1. Examine inventory and quarantine any affected devices 2. Cease usage of the product with immediate effect 3. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization 4. Even if you no longer have the device, Olympus requests that you acknowledge receipt of this letter through the Olymps portal 5. Please forward this notice to other users who may have the affected products if you have further distributed it.
Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
444 units