The Recall Desk
HighFDA (Devices)·Z-1001-2025·Announced 2025-01-29

Olympus Thunderbeat Hand Instruments Recalled for Probe Tip Damage and Breaking

Olympus is recalling Thunderbeat hand instruments because probe tips can be damaged or break, and pads can detach during use. No injuries have been reported.

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 no reported injuries or illnesses. The hazard presents a risk of device failure during surgical procedures, but no actual harm has been reported. This meets the criterion for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling the Thunderbeat Front-Actuated Grip Type S Hand Instrument (Model TB-0520FCS, Catalog Number N5423930). This sterile, single-use surgical instrument is designed for use with the Ultrasonic Generator (USG-400), Electrosurgical Generator (WSG-400), and Thunderbeat Transducer (TD-TB400) in surgical procedures.

The probe tips of these instruments are being damaged or breaking during use, and the pads can become detached. These failures could compromise instrument function during surgical procedures.

Approximately 84,570 units have been distributed worldwide, including 4,489 units in the United States. The recall affects all lots of Model TB-0520FCS.

Customers who have received these instruments should stop using them and contact Olympus Corporation of the Americas for replacement or return instructions. Healthcare providers should verify their inventory and remove affected units from service.

The recalled product

Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5423930 Software Version: N/A Product Description: Thunderbeat instrument is a
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Hand Instruments
Hazard
  • device-failure
  • 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-0520FCS
  • Catalog Number/Product Code: N5423930
  • UDI: 04953170383571
  • 04953170383578
  • Lots: All

Distribution

Distributed nationwide across the United States.

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