Z-0996-2025Class II

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35...

Name: Z-0996-2025 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35...
Creator: Olympus Corporation of the Americas
Published: 2024-11-25
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-11-25 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number... on 2024-11-25. FDA classified it as Class II and gives the reason as "The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0996-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-25
Posted: 2025-01-21
Recalling firm: OLYMPUS Corporation of the Americas
Product: Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423730 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
FDA root cause: Under Investigation by firm
Action: On December 20, 2024, URGENT FIELD SAFETY NOTICE: ADVISORY letters were sent to customers. Actions Required: Olympus requires you to take the following actions: 1. Carefully read the content of this FSN. 2. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this FSN and the relevant IFU. 3. Olympus requests that you acknowledge receipt of this FSN through our web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number "0462 c. Complete the form as instructed and include your account ID number: [XXXXXXXX] d. Indicating in the comments if you would like to receive in-service training to support the correct use of this device. 4. If you have further distributed this product, identify your customers, and forward this FSN to them. Olympus requests that you report any complaints, including probe damage or pad detachment, to Technical Assistance Center (TAC) at 1- 800-848-9024 (option 1), and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation. If you require additional information, please do not hesitate to contact me by phone at (647) 999-3203 or by e-mail at [email protected].
Quantity in commerce: 128,608 units (OUS ONLY)
Distribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepale, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Yemen.
Product codes and lots: Model: TB-0535FCS; Catalog Number/Product Code: N5423730; UDI: 04953170383557, 04953170383554; Lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0996-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0993-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-21
Z-0994-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-21
Z-0995-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-21
Z-0996-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-21
Z-0997-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-21
Z-0998-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-21
Z-0999-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-21
Z-1000-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-21
Z-1001-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-21
Z-1002-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-21
Z-1003-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-21

Product code LFL

K211838UnclassifiedUltrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation / cleared 2021-08-04

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)