FDA-Device2026-02-25Class IIOTHER
Olympus Thunderbeat 5mm surgical instrument recalled for adverse events
OTHERNationwide distribution
Stop using Olympus Thunderbeat surgical instruments
Olympus Corporation is removing Olympus Thunderbeat 5 mm, 45 cm pistol grip surgical instruments (Model TB-0545PC) from the market due to ongoing reports of adverse events during use. This Class II recall affects approximately 30 units distributed worldwide, including the United States, Brazil, Canada, Germany, Mexico, and Japan.
- Stop using the affected Olympus Thunderbeat instrument immediately
- Contact Olympus Corporation of the Americas for instructions on return or replacement
- Review your facility's inventory using Model No. TB-0545PC and UDI 04953170308635
- Report any adverse events or injuries to the FDA 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
30 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1377-2026More 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
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief