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Open, Classified

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.

FDA Recall Z-1852-2026 · Posted 2026-04-17

Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeGEI
Date Initiated2026-03-23
Product Quantity365 units

Reason for Recall

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

Firm Action

Olympus notified consignees on about 03/23/2026 via emailed letter. Consignees were instructed to immediately cease use of all THUNDERBEAT II devices, examine inventory for affected product and quarantine any on hand, and complete, return the Reply Form provided and arrange for the return of all affected units in inventory. Consignees were also instructed to notify other users if the affected products were transferred or further distributed.

Root Cause

Device Design

Distribution Pattern

International distribution in the countries of Australia, Japan, Hong Kong, and Europe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)Olympus Medical Systems Corporation · 2025-10-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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