FDA-Device2026-02-25Class IIPROCESSING DEFECT
Olympus Thunderbeat 5 mm surgical instrument recalled for adverse events
OTHERNationwide distribution
Stop using Olympus Thunderbeat surgical instruments
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
Hazard
Firm is initiating a removal due to continued reports of adverse events.
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 Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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