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FDA-Device2026-04-01Class IIPROCESSING DEFECT

Olympus Everest Bipolar Cutting Forceps recalled for defective welds causing jaw breakage

Olympus
OTHERNationwide distribution

Stop using Olympus Everest Bipolar Cutting Forceps

Olympus has recalled its Everest Bipolar Cutting Forceps (Model 3005) used in minimally invasive surgery because some units contain defective welds in their components. The jaw of the forceps can break during use due to these faulty welds. This affects 106 units distributed worldwide.

  • Stop using Olympus Everest Bipolar Cutting Forceps Model 3005 immediately
  • Check your facility's inventory for affected units (all unexpired lots from supplier are recalled)
  • Contact Olympus Corporation of the Americas for instructions on replacement or return
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
106 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1638-2026

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