FDA-Device2026-02-25Class IIOTHER
Olympus Thunderbeat 5mm surgical instrument recalled for adverse event reports
OTHERNationwide distribution
Stop using Olympus Thunderbeat surgical instruments
Olympus is recalling the Thunderbeat 5 mm, 35 cm inline grip surgical instrument (Model TB-0535IC) due to ongoing reports of adverse events during use. This medical device is used in surgical procedures and distributed worldwide.
- Stop using the affected device immediately if you have one
- Check the model number TB-0535IC and UDI 04953170464973 on your device
- Contact your Olympus representative or the FDA for instructions on return or replacement
- Report any injuries or problems to the FDA's MedWatch program
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
52 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1380-2026More Olympus Corporation of the Americas recalls
- FDA-Device2026-07-29Olympus High Flow Insufflation Unit UHI-4 recalled for unexpected display shutdown and air delivery loss
- FDA-Device2026-07-29Olympus OEV321UH 4K UHD LCD Monitor recalled for faulty HDMI and DisplayPort connectors
- FDA-Device2026-07-22Olympus Ellik Evacuator Model 194 recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
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