FDA-Device2026-02-25Class IIPROCESSING DEFECT
Olympus Thunderbeat 5mm surgical instrument recalled due to adverse event reports
What this means
Olympus Corporation is removing Thunderbeat 5mm pistol grip surgical instruments (Model TB-0535PC) from the market worldwide due to ongoing reports of adverse events during use. No specific injuries have been reported, but the company is taking action out of caution.
- If your facility uses this device, stop using it immediately
- Contact Olympus Corporation of the Americas for return or replacement instructions
- Check your inventory for Model TB-0535PC with all lot 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
3,381 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1378-2026More 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.