FDA-Device2026-02-25Class IIPROCESSING DEFECT
Olympus Thunderbeat surgical instrument recalled due to adverse event reports
What this means
Olympus Corporation is removing Thunderbeat 5 mm, 20 cm surgical instruments (Model TB-0520FCS) from the market due to ongoing reports of adverse events during use. The company has identified a safety concern affecting all lots of this device.
- Stop using the Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S instrument immediately
- Contact Olympus Corporation for instructions on returning or replacing the device
- Check your facility's inventory for Model TB-0520FCS and quarantine any units found
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
4,181 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1373-2026More 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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