The Recall Desk
HighFDA (Devices)·Z-1000-2025·Announced 2025-01-29

Olympus Thunderbeat Surgical Instruments Recalled for Damaged Probe Tips

Olympus Corporation is recalling Olympus Thunderbeat surgical hand instruments (Model TB-0545FCS) due to probe tips that are being damaged or breaking, which may affect instrument function during medical procedures.

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 a Class II medical device recall with a real risk of harm from broken or damaged probe tips. No illnesses or injuries have been reported, which aligns with the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling the Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument, Model TB-0545FCS (Catalog Number N5423510). A total of 112 units have been recalled. These instruments are intended for use with the Ultrasonic Generator (USG-400), Electrosurgical Generator (WSG-400), and Thunderbeat Transducer (TD-TB400).

The probe tips of these hand instruments are being damaged or breaking, including pad damage and detachment. These defects may affect instrument performance and safety during surgical procedures.

The recalled instruments were distributed internationally to healthcare facilities outside the United States. Healthcare facilities and medical professionals with these instruments should contact Olympus Corporation of the Americas for instructions regarding replacement, correction, or return of the affected devices.

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: N5423510 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
112

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: N5423510
  • UDI: 04953170383533
  • 04953170383530
  • 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

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Same hazard · probe tip damage

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