FDA-Device2026-02-25Class IIPROCESSING DEFECT
Olympus Thunderbeat 5mm surgical device recalled due to adverse event reports
What this means
Olympus is recalling its Thunderbeat 5 mm, 35 cm Front-Actuated Grip Type S surgical instruments (Model TB-0535FCS) due to ongoing reports of adverse events. The recall affects 88,268 units distributed worldwide, including in the United States, Brazil, Canada, Germany, Mexico, and Japan.
- Stop using the affected Thunderbeat devices immediately
- Check the model number TB-0535FCS and lot information on your device
- Contact Olympus Corporation of the Americas for device return and replacement instructions
- Report any injuries or complications from use to the FDA MedWatch program
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
88,268 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1372-2026More 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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