# FDA recall Z-0993-2025

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2024-11-25.

## 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: 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).

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-0993-2025
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-25
- **Report date:** 2025-01-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0993-2025

## Citation

> AI Analytics. FDA recall Z-0993-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0993-2025. Source: US FDA. Licensed CC0.

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