CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report

Thunderbeat, Front-actuated Grip Type S recalled

Olympus Corporation of the Americas is recalling Thunderbeat, Front-actuated Grip Type S, distributed nationwide in the US. The recall was initiated on 25 Nov 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: TB-0535FCS; Catalog Number/Product Code: R5000687; UDI: 04953170409677 and 04953170383540; Lots: All

Quantity recalled495,865 units (96,253 US, 399,612 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0993-2025
FDA event ID: 95950
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 25 Nov 2024
FDA classified: 21 Jan 2025
Reported: 29 Jan 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

25 Nov 2024	Recall initiated by company
21 Jan 2025	Classified by FDA	+57 days
29 Jan 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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: R5000687 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).

Where it was distributed

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.

Nationwide Georgia

Questions about this recall

Is Thunderbeat, Front-actuated Grip Type S recalled?

Yes. Olympus Corporation of the Americas recalled Thunderbeat, Front-actuated Grip Type S on 25 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0993-2025.

Why was it recalled?

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Which lots are affected?

Model Number: TB-0535FCS; Catalog Number/Product Code: R5000687; UDI: 04953170409677 and 04953170383540; Lots: All

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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