FDA-Device2026-04-01Class IIPROCESSING DEFECT
Olympus PK Cutting Forceps recalled for defective welds causing jaw breakage
OTHERNationwide distribution
Stop using Olympus PK Cutting Forceps model PK-CF0533
Olympus PK Cutting Forceps (model PK-CF0533) contain welding defects that can cause the instrument's jaw to break during surgical use. The supplier did not properly validate the welding process on affected components. This could compromise the forceps' function during endoscopic or open surgical procedures.
- Stop using Olympus PK Cutting Forceps model PK-CF0533 immediately
- Contact Olympus Corporation of the Americas for device removal or replacement instructions
- Check your facility's inventory for lot numbers and verify expiration status
- Report any injuries or device failures to the FDA MedWatch program
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.
Sold states
Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
Affected count
444 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1640-2026More Olympus Corporation of the Americas recalls
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- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
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