HIGH

Olympus Thunderbeat Surgical Device Recalled Over Adverse Events

Olympus Corporation of the Americas recalled the Thunderbeat surgical device on October 22, 2025, due to reports of adverse events. The recall affects 30 units distributed worldwide, including the US, Canada, and Japan. Patients and healthcare providers must stop using the device immediately.

Quick Facts at a Glance

Recall Date
October 22, 2025
Hazard Level
HIGH
Brand
Olympus Corporation of the Americas
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Firm is initiating a removal due to continued reports of adverse events.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Olympus Thunderbeat is a surgical device used in minimally invasive procedures. Healthcare professionals purchase it for its advanced capabilities in cutting and coagulation.

Why This Is Dangerous

The hazard arises from adverse events which could potentially lead to complications during surgical procedures. Users must cease use to mitigate any risks associated with these incidents.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers must halt usage of this device, which may cause disruptions in surgical schedules and patient care.

Practical Guidance

How to identify if yours is affected

  1. Check your device for model number TB-0545IC.
  2. Verify if your device has the UDI number 04953170308673.
  3. Contact your healthcare provider if unsure about your device.

Where to find product info

Model and UDI numbers can typically be found on the packaging or directly on the device.

What timeline to expect

Expect a refund or replacement processing time of approximately 4-6 weeks after returning the device.

If the manufacturer is unresponsive

  • Contact customer service again for follow-up.
  • Document all communications regarding the return.
  • Consider filing a complaint with regulatory authorities if unresponsive.

How to prevent similar issues

  • Look for devices with updated safety certifications.
  • Research product reviews for adverse event reports before purchase.
  • Consult with healthcare professionals about device safety.

Documentation advice

Keep copies of any receipts and correspondence with Olympus regarding the recall as part of your records.

Product Details

The recalled product is the Olympus Thunderbeat, 5 mm, 45 cm Inline Grip, Model No. TB-0545IC. The device has a Unique Device Identifier (UDI) of 04953170308673. The recall affects all lots.

Key Facts

  • Recall date: October 22, 2025
  • Quantity recalled: 30 units
  • Affected regions: Worldwide including the US and Canada
  • Immediate action required for users
  • Reports of adverse events noted

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Model No. TB-0545IC
UDI: 04953170308673
All Lots.
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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