The Recall Desk
HighFDA (Devices)·Z-1003-2025·Announced 2025-01-29

Olympus Thunderbeat Surgical Instruments Recalled for Probe Tip Damage

Olympus is recalling Thunderbeat hand instruments (Model TB-0535FCS) because probe tips can be damaged or break during use. The recall affects 27,352 units distributed internationally.

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 of a surgical device with a real defect (probe tip damage and pad detachment) that could impair instrument function during surgical use. No patient illnesses or injuries are reported in the source text. Per the rubric, a risk-of-harm product where injury has not yet been reported scores 3 (High).

Plain-English summary

Olympus Corporation of the Americas is recalling the Thunderbeat (Model TB-0535FCS), a sterile, single-use surgical hand instrument intended for use with Olympus ultrasonic and electrosurgical generators. The instrument is 5MM in diameter, 35CM in length, with a front-actuated grip design.

The probe tips of these instruments are being damaged or breaking, including damage to and detachment of the pads. This defect could compromise instrument performance during surgical procedures.

The recall affects 27,352 units distributed internationally outside the United States. All lots of Model TB-0535FCS are included in the recall.

Healthcare facilities that received these instruments should discontinue use immediately and contact Olympus Corporation of the Americas for instructions regarding return or replacement of the recalled units.

The recalled product

Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S¿ Model Number: TB-0535FCS Catalog Number/Product Code: N5423810 Software Version: N/A Product Description: Thunderbeat instrument is a
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical instrument
Hazard
  • probe-tip-damage
  • pad-detachment
  • device-failure

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-0535FCS
  • Catalog Number/Product Code: N5423810
  • UDI: 04953170383564
  • 04953170383561
  • Lots: All

Distribution

Distributed nationwide across the United States.

Related recalls

Same category