Recall Z-1854-2026— Olympus Corporation of the Americas

Name: FDA recall Z-1854-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-23

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2026-03-23. It names one FDA 510(k) clearance: K252150. Product: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.. Reason: Potential for detachment of a distal tip component of the device during use..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2026-03-23
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K252150 — Ultrasonic Bipolar Generator (USG-410) +5 moreOlympus Medical Systems Corporation·cleared 2025-10-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.

Reason for recall

Potential for detachment of a distal tip component of the device during use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.