FDA-Device2026-02-25Class IIPROCESSING DEFECT
Olympus Thunderbeat 5 mm surgical instrument recalled due to adverse event reports
What this means
Olympus Corporation is removing the Thunderbeat 5 mm, 45 cm Front-Actuated Grip Type S surgical instrument from use worldwide due to ongoing reports of adverse events during use. This affects approximately 9,542 units across the US and several other countries.
- Stop using the Olympus Thunderbeat model TB-0545FCS immediately if you have one
- Check the UDI numbers on your device: 04953170383533, 04953170383526, 04953170409684, or 04953170383519
- Contact Olympus Corporation for instructions on returning or replacing the device
- Report any injuries or problems 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
9,542 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1371-2026More 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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