FDA-Device2026-04-01Class IIPROCESSING DEFECT
Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
What this means
Olympus Corporation has recalled its PKS Cutting Forceps (Model 3005PK) used during minimally invasive surgery. The device contains components with defective welds that were not properly validated by the supplier. If the jaw breaks during use, it could affect the procedure and patient safety.
- Stop using Olympus PKS Cutting Forceps Model 3005PK immediately
- Contact your facility's surgical equipment manager or Olympus directly for instructions on device replacement or return
- Review your inventory for affected units (all unexpired lots are included)
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
93 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK 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-1642-2026More Olympus recalls
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- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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