Z-1851-2026Class II

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC

Name: Z-1851-2026 Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC
Creator: Olympus Corporation of the Americas
Published: 2026-03-23
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2026-03-23 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC on 2026-03-23. FDA classified it as Class II and gives the reason as "Potential for detachment of a distal tip component of the device during use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1851-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-23
Posted: 2026-04-17
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Potential for detachment of a distal tip component of the device during use.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 830 units
Distribution: International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
Product codes and lots: Model Number: TB2-0520FC. UDI-DI Number: 04953170439995. All Lot Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1851-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1851-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1852-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1853-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17
Z-1854-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-17

Product code GEI

K252150Class IIUltrasonic 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 / cleared 2025-10-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)