FDA-Device2026-04-01Class IIPROCESSING DEFECT
Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
OTHERNationwide distribution
Stop using Olympus PKS Cutting Forceps
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.
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
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 Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus OER-Pro endoscope reprocessor incompatible with MAJ-1443 and MAJ-1444 adapters
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