FDA-Device2026-02-25Class IIPROCESSING DEFECT
Olympus Thunderbeat 5mm surgical device recalled due to adverse event reports
What this means
Olympus Corporation is removing Thunderbeat 5 mm, 20 cm surgical instruments from the market due to ongoing reports of adverse events during use. About 140 units with model number TB-0520IC have been distributed worldwide, including across the US and in Brazil, Canada, Germany, Mexico, and Japan.
- Stop using the affected Thunderbeat device immediately if you have one
- Contact Olympus Corporation for instructions on return or replacement
- Check your facility's inventory for model TB-0520IC with the listed UDI numbers
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
140 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1381-2026More 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.