The Recall Desk
HighFDA (Devices)·Z-0996-2025·Announced 2025-01-29

Olympus Thunderbeat Surgical Hand Instruments Recalled for Probe Damage

Olympus Corporation is recalling Olympus Thunderbeat front-actuated surgical hand instruments (Model TB-0535FCS) due to damaged or breaking probe tips and pad detachment. Approximately 128,608 units distributed outside the US are affected.

What this means for you

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 with a known structural defect (damaged or breaking probe tips), but the source text does not report any injuries or illnesses. Per the rubric, a risk-of-harm medical device without reported injury is classified as High.

Plain-English summary

Olympus Corporation of the Americas is recalling Olympus Thunderbeat front-actuated surgical hand instruments (Model TB-0535FCS, Catalog Number N5423730). These are sterile, single-use items designed for use with the Ultrasonic Generator (USG-400), Electrosurgical Generator (WSG-400), and Thunderbeat Transducer (TD-TB400) during surgical procedures.

The probe tips of the hand instruments are being damaged or breaking, including pad damage and detachment. This defect affects the structural integrity and proper function of the surgical instrument.

Approximately 128,608 units were distributed outside the United States to healthcare facilities worldwide, including countries in North America, Europe, Asia, Africa, and other regions. The recall includes all lots of the affected model (TB-0535FCS with UDI 04953170383557 and 04953170383554).

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: N5423730 Software Version: N/A Product Description: Thunderbeat instrument is a
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Instrument
Hazard
  • probe-tip-damage
  • component-detachment

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: N5423730
  • UDI: 04953170383557
  • 04953170383554
  • Lots: All

Distribution

Distributed nationwide across the United States.

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