The Recall Desk
HighFDA (Devices)·Z-0998-2025·Announced 2025-01-29

Olympus Thunderbeat Surgical Instrument Recalled for Damaged or Breaking Probe Tips

Olympus is recalling approximately 9,200 units of Thunderbeat surgical hand instruments distributed worldwide because probe tips can become damaged, break, or pads can detach during use.

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: FDA Class II recall with a mechanical defect that represents a risk of harm during surgical use, but with no reported injuries or illnesses. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling approximately 9,200 units of the Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument (Model TB-0545FCS, Catalog Number N5423330). This is a sterile, single-use surgical instrument intended for use with specific Olympus electrosurgical and ultrasonic generators and transducers.

The probe tips of these instruments can become damaged or break during use, and the instrument pads may separate from the device. This defect could compromise the instrument's ability to function properly during surgical procedures.

The affected units were distributed outside the United States to hospitals and surgical centers in numerous countries worldwide. All lots of this product have been recalled.

Healthcare facilities that have received these instruments should immediately stop using them and contact Olympus Corporation of the Americas for instructions on return or disposal of the affected products.

The recalled product

Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423330 Software Version: N/A Product Description: Thunderbeat instrument is a s
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Instrument
Hazard
  • probe-tip-damage
  • pad-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-0545FCS
  • Catlog Number/Product Code: N5423330
  • UDI: 04953170383519
  • 04953170383516
  • Lots: All

Distribution

Distributed nationwide across the United States.

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