Recalls / —

—#217855

Product

Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip

FDA product code

LFL — Instrument, Ultrasonic Surgical

Device class

Class U

Medical specialty

Unknown

510(k) numbers

K111202

Affected lot / code info

Model No. TB-0535FC; UDI: 04953170337574, 04953170464959; All Lots.

Why it was recalled

Firm is initiating a removal due to continued reports of adverse events.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An URGENT MEDICAL DEVICE PRODUCT REMOVAL notification was mailed to consignees on 12/22/25. The notification instructs consignees to examine inventory for affected devices, immediately cease use and quarantine devices, and contact Customer Service at 1-800-848-9024 (option 2) to obtain a Return Materials Authorization. Credit will be issued to consignees upon return of devices. If product has been further distributed, consignees are to forward the provided notification. Consginees with any questions can contact Cynthia Ow at Cynthia.Ow@Olympus.com or by phone at 674-999-3203.

Recalling firm

Firm

Olympus Corporation of the Americas

Address

3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.

Timeline

Recall initiated

2025-10-22

Posted by FDA

2026-02-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #217855. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.