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FDA-Device2026-02-25Class IIOTHER

Olympus Thunderbeat 5mm surgical instrument recalled for adverse events

Olympus
OTHERNationwide distribution

Stop using Olympus Thunderbeat surgical instruments

Olympus Corporation is removing Olympus Thunderbeat 5 mm, 45 cm pistol grip surgical instruments (Model TB-0545PC) from the market due to ongoing reports of adverse events during use. This Class II recall affects approximately 30 units distributed worldwide, including the United States, Brazil, Canada, Germany, Mexico, and Japan.

  • Stop using the affected Olympus Thunderbeat instrument immediately
  • Contact Olympus Corporation of the Americas for instructions on return or replacement
  • Review your facility's inventory using Model No. TB-0545PC and UDI 04953170308635
  • Report any adverse events or injuries 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
30 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1377-2026

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