FDA-Device2026-02-25Class IIPROCESSING DEFECT
Olympus Thunderbeat 5mm surgical instrument recalled due to adverse event reports
OTHERNationwide distribution
Stop using Olympus Thunderbeat surgical instruments
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
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
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 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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