The Recall Desk
HighFDA (Devices)·Z-0993-2025·Announced 2025-01-29

Olympus Thunderbeat surgical instrument probe tips breaking and detaching

Olympus is recalling Thunderbeat surgical instruments due to probe tip damage, breaking, and pad detachment.

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 for a surgical instrument with proven device malfunction (breaking probe tips, detaching pads). No injuries or illnesses reported in the source. Per the rubric, this qualifies as Score 3 (High): risk-of-harm products where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling Olympus Thunderbeat surgical instruments, Model TB-0535FCS (Catalog Number R5000687). These are sterile, single-use instruments intended for use with ultrasonic and electrosurgical generators during surgical procedures.

The recalled instruments have defective probe tips that are being damaged or breaking during use. In addition, pads on the instruments are sustaining damage and may detach.

The recall affects approximately 96,253 units distributed in the United States and 399,612 units distributed internationally to over 60 countries. Healthcare facilities using or storing these instruments are potentially affected.

Healthcare providers should immediately discontinue use of the recalled instruments and contact Olympus Corporation for further instructions. Facilities should identify and remove affected instruments from service.

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: R5000687 Software Version: N/A Product Description: Thunderbeat instrument is a
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Instrument
Hazard
  • probe-breakage
  • pad-detachment
  • device-malfunction

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 (4)

  • Model Number: TB-0535FCS
  • Catalog Number/Product Code: R5000687
  • UDI: 04953170409677 and 04953170383540
  • Lots: All

Distribution

Distributed nationwide across the United States.

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