FDAClass II · Medical device · Recalled April 29, 2026

Olympus Thunderbeat II Shears w/Ultrasonic Mode recall — Olympus Corporation of the Americas

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1853-2026
Brand: Olympus of the Americas
Classification: Class II
Units affected: 3,360 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.

Affected products

Olympus Thunderbeat II Shears w/Ultrasonic Mode

Companies & origin

Recalling firm location: Center Valley, PA, United States
Firm address: 3500 Corporate Pkwy, N/A, 18034-8229

Identifying details (verbatim from the notice)

Product codes / lots: Model Number: TB2-0535FC. UDI-DI: 04953170440014. All Lot Numbers.
Distribution: International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
Firm notified the public via: E-Mail
FDA event ID: 98550
Recall initiated: March 23, 2026
FDA classified: April 17, 2026
FDA report date: April 29, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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