Recall Z-1378-2026— Olympus Corporation of the Americas

Name: FDA recall Z-1378-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-22

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2025-10-22. It names one FDA 510(k) clearance: K111202. Product: Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip. Reason: Firm is initiating a removal due to continued reports of adverse events..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2025-10-22
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K111202 — SURGICAL TISSUE MANAGEMENT SYSTEMOlympus Medical Systems Corp.·cleared 2012-01-20

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, 5mm, 35 cm, Pistol Grip

Reason for recall

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

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