FDA-Device2026-02-25Class IIPROCESSING DEFECT
Olympus Thunderbeat 5mm surgical instrument recalled due to adverse events
What this means
Olympus is recalling the Thunderbeat 5 mm, 45 cm Front-Actuated Grip surgical instrument (Model TB-0545FC) worldwide due to continued reports of adverse events during use. The company has determined that removal of this device from the market is necessary.
- Stop using this device immediately if you have it in stock or in clinical use.
- Contact Olympus Corporation of the Americas for instructions on device return or replacement.
- Check your facility's inventory using Model No. TB-0545FC or UDI 04953170337543.
The agency's original wording
Hazard
Firm is initiating a removal due to continued reports of adverse events.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Affected count
0 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1374-2026More Olympus recalls
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- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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