Olympus Thunderbeat surgical instrument probe tips may damage or break
Olympus is recalling Thunderbeat surgical hand instruments due to damaged or breaking probe tips that may occur during use and affect surgical procedure safety.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a surgical instrument with mechanical defect—probe tips damaged or breaking during use. Although no hospitalizations or injuries are documented in the source, the failure of a surgical instrument component poses a risk of patient harm, meeting the rubric criterion for High severity.
Plain-English summary
Olympus Corporation of the Americas is recalling the Thunderbeat 5 mm, 20 cm Front-Actuated Grip Type S Hand Instrument (Model TB-0520FCS). The device is a sterile, single-use surgical instrument intended for use with the Ultrasonic Generator (USG-400), Electrosurgical Generator (WSG-400), and compatible transducers.
The recall was initiated because probe tips on these instruments are being damaged or breaking, including pad damage and detachment. This defect can affect instrument performance during surgical procedures.
The recall affects 11,329 units distributed outside the United States to healthcare facilities in numerous countries worldwide, including Canada, Australia, Japan, and throughout Europe, Asia, Africa, and the Middle East.
Healthcare facilities that have received these instruments should stop using them and contact Olympus Corporation of the Americas for replacement or return instructions. Patients or healthcare providers with concerns about device safety should contact the manufacturer or the U.S. Food and Drug Administration.
The recalled product
- Product
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424110¿ Software Version: N/A Product Description: Thunderbeat instrument is…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 11,329
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model: TB-0520FCS
- Catalog Number/Product Code: N5424110¿
- UDI: 04953170383595
- 04953170383592
- Lots: All
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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FDA (Devices) · 2025-01-29
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