Olympus Corporation of the Americas: Medical Device Recall in 2026 - (Recall #: Z-1375-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 22, 2025

Date Posted: February 25, 2026

Recall Number: Z-1375-2026

Event ID: 98188

Reason for Recall:

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

Status: Ongoing

Product Quantity: 0 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated