FDA-Device2026-02-25Class IIPROCESSING DEFECT
Olympus Thunderbeat 5 mm surgical instrument recalled for adverse events
What this means
Olympus Corporation is recalling the Thunderbeat 5 mm, 20 cm front-actuated grip surgical instrument due to continued reports of adverse events during use. The recall affects all lots of this model worldwide, including the US and several other countries.
- Stop using the affected Olympus Thunderbeat instrument immediately
- Contact Olympus Corporation of the Americas for instructions on device return or replacement
- Review any patient records associated with use of this device
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, 20 cm, Front-Actuated Grip
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1376-2026More Olympus recalls
- FDA-Device2026-07-29Olympus OEV321UH 4K UHD LCD Monitor recalled for faulty HDMI and DisplayPort connectors
- FDA-Device2026-07-29Olympus High Flow Insufflation Unit UHI-4 recalled for unexpected display shutdown and air delivery loss
- 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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