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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Olympus Corporation of the Americas
- Product type
- Surgical Instrument
- Model numbers
- Model No. TB-0545FC, UDI: 04953170337543, All Lots.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 22, 2025
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
March 4, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
The Olympus Thunderbeat is a surgical instrument designed for use in medical procedures. Surgeons and healthcare providers use this device for its advanced features in tissue dissection and coagulation.
Why This Is Dangerous
The hazard stems from reported adverse events associated with the device, which could compromise patient safety during surgical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers and patients as it requires immediate cessation of usage, which can disrupt scheduled medical procedures and impact patient care.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device to see if it matches TB-0545FC.
- Review any communication from Olympus regarding the recall for specific instructions.
- If in doubt, contact your healthcare provider for confirmation.
Where to find product info
The model number and UDI can typically be found on the packaging or the device itself.
What timeline to expect
Expect a response from Olympus within 4-6 weeks regarding the return process or refund.
If the manufacturer is unresponsive
- Document all communication attempts with Olympus.
- Reach out to the FDA if further assistance is needed.
How to prevent similar issues
- Choose devices with FDA approval and check for recent recalls before purchasing.
- Consult with your healthcare provider about alternative products before surgery.
Documentation advice
Keep copies of any receipts, correspondence with Olympus, and notes on the device's use.
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Product Details
The recalled product is the Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip, Model No. TB-0545FC. It has worldwide distribution, including the US, Canada, Brazil, Germany, Mexico, and Japan.
Key Facts
- Recalled product: Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
- Recall date: October 22, 2025
- Distribution: Worldwide, including the US and Canada
- Adverse events reported, prompting recall
- Patients and providers must stop using the device immediately
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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