Class IIReported 2026-02-25

Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip

Reason for Recall

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

Recall Number

Z-1380-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-10-22

Reported

2026-02-25

Distribution

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

Code Info

Model No. TB-0535IC; UDI: 04953170464973; All Lots.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.