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FDA-Device2026-04-01Class IIPROCESSING DEFECT

Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage

Olympus
OTHERNationwide distribution

Stop using Olympus PKS Cutting Forceps

Olympus discovered that some PKS Cutting Forceps (Model 920005PK) have defective welds in their components. During surgery, the forceps' jaw can break due to these weak welds, potentially affecting the procedure.

  • Stop using affected Olympus PKS Cutting Forceps (Model 920005PK, all unexpired lots)
  • Contact your facility's equipment manager or Olympus customer service for replacement or guidance
  • Check your surgical equipment inventory for this model
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
326 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: 920005PK 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-1644-2026

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