FDA-Device2026-02-25Class IIPROCESSING DEFECT
Olympus Thunderbeat 5mm surgical instrument recalled due to adverse event reports
What this means
Olympus is removing the Thunderbeat 5 mm, 35 cm, Front-Actuated Grip surgical instrument (Model TB-0535FC) from distribution due to ongoing reports of adverse events during use. The device has been distributed worldwide, including across the US and several other countries.
- Stop using the affected Olympus Thunderbeat device immediately
- Contact Olympus or your healthcare facility for instructions on returning or replacing the instrument
- Review any patient cases where this device was used and follow your facility's protocols for patient follow-up if needed
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, 35 cm, Front-Actuated Grip
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1375-2026More Olympus recalls
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- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
- 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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