Olympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips
Olympus recalls 54,500 Thunderbeat surgical hand instruments due to probe tips that may be damaged or break. These sterile devices are used in ultrasonic surgical procedures.
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: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard represents a risk-of-harm product—broken or damaged probe tips could compromise surgical procedures—but without documented adverse events, the severity is classified as High per the rubric.
Plain-English summary
Olympus Corporation of the Americas is recalling 54,500 Thunderbeat 5 mm, 35 cm Front-Actuated Grip Type S hand instruments (Model TB-0535FCS). These are sterile, single-use surgical devices intended for use with the Olympus Ultrasonic Generator (USG-400), Electrosurgical Generator (WSG-400), and Thunderbeat Transducer.
The probe tips of the recalled instruments are being damaged or breaking, including pad damage and detachment. This defect was identified by the manufacturer.
Healthcare facilities and surgical centers that have received these instruments should discontinue use immediately and contact Olympus Corporation of the Americas to arrange for replacement or return of the affected devices.
The recall affects 54,500 units distributed outside the United States.
The recalled product
- 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: N5423630 Software Version: N/A Product Description: Thunderbeat instrument is a…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 54,500
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-0535FCS
- Catalog Number/Product Code: N5423630
- UDI: 04953170383540
- 04953170383547
- 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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