The Recall Desk
HighFDA (Devices)·Z-0999-2025·Announced 2025-01-29

Olympus Thunderbeat Surgical Instrument Recalled for Damaged Probe Tips

Olympus is recalling the Thunderbeat 5 mm surgical hand instrument due to damaged or broken probe tips and pads. The defect may affect surgical function and device performance.

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 recall with no reported injuries, illnesses, or deaths. The defect—damaged or broken probe tips—represents a risk-of-harm product used in surgical procedures. The absence of reported actual harm keeps the severity at High rather than Severe.

Plain-English summary

Olympus Corporation of the Americas is recalling the Thunderbeat Front-Actuated Grip Type S Hand Instrument (Model TB-0545FCS), a sterile, single-use surgical device intended for use with electrosurgical and ultrasonic generators during surgical procedures.

The probe tips of the instruments are being damaged or broken, including pad damage and detachment. This defect may compromise the instrument's functionality during surgical use.

Approximately 4,055 units have been distributed outside the United States to healthcare providers and medical facilities in multiple countries worldwide. All lots of the affected model are included in this recall.

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: N5423430 Software Version: N/A Product Description: Thunderbeat instrument is a s
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Instrument
Hazard
Affected units
4,055

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
  • Catalog Number/Product Code: N5423430
  • UDI: 04953170383526
  • 04953170383523
  • 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.

See all 11 products in this recall →

Related recalls

Same manufacturer · Olympus Corporation of the Americas

See all →

Same hazard · probe damage

See all →