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FDA-Device2026-02-25Class IIPROCESSING DEFECT

Olympus Thunderbeat 5 mm surgical instrument recalled due to adverse event reports

Olympus
OTHERNationwide distribution

Stop using Olympus Thunderbeat surgical instruments

Olympus Corporation is removing the Thunderbeat 5 mm, 45 cm Front-Actuated Grip Type S surgical instrument from use worldwide due to ongoing reports of adverse events during use. This affects approximately 9,542 units across the US and several other countries.

  • Stop using the Olympus Thunderbeat model TB-0545FCS immediately if you have one
  • Check the UDI numbers on your device: 04953170383533, 04953170383526, 04953170409684, or 04953170383519
  • Contact Olympus Corporation for instructions on returning or replacing the device
  • Report any injuries or problems to the FDA MedWatch program
Hazard

Firm is initiating a removal due to continued reports of adverse events.

Sold states
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Affected count
9,542 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1371-2026

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