FDA-Device2026-04-01Class IIPROCESSING DEFECT
Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
What this means
Olympus PKS Cutting Forceps (Model 920000PK) contain welding defects that can cause the instrument's jaw to break during surgery. The supplier did not properly validate the welding process on affected components. This affects 7 units distributed worldwide.
- Stop using the Olympus PKS Cutting Forceps Model 920000PK immediately.
- Contact Olympus Corporation of the Americas for instructions on return or replacement.
- Verify your device lot number matches the recall—all unexpired lots are affected.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
Affected count
7 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1643-2026More Olympus recalls
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- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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