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 Device
- Model numbers
- Model No. TB-0520IC, UDI: 04953170308581, 04953170608710, 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 device used in various medical procedures. It combines cutting and coagulation functionalities, making it valuable in surgeries.
Why This Is Dangerous
The recall was initiated due to reported adverse events which could potentially harm patients. The exact nature of the risks has not been specified, but they are serious enough to stop device use immediately.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers and healthcare providers must act quickly to stop using this device, which may disrupt medical procedures and patient care.
Practical Guidance
How to identify if yours is affected
- Check the model number of your device against the recall notice.
- Verify the UDI number on the device packaging.
- Consult your healthcare provider for confirmation on the recall status.
Where to find product info
You can find the model number and UDI on the product's packaging or directly on the device itself.
What timeline to expect
Expect a response from Olympus within a few weeks regarding the recall process and any necessary steps.
If the manufacturer is unresponsive
- Contact Olympus customer service for updates.
- Consult the FDA website for further information.
- Document your communication attempts for records.
How to prevent similar issues
- Look for devices with robust safety certifications.
- Research alternative devices that have a good safety record.
- Consult with healthcare professionals about device safety before use.
Documentation advice
Keep a record of your purchase, correspondence with Olympus, and any health incidents related to the device.
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Product Details
The Olympus Thunderbeat is a 5 mm, 20 cm surgical device. It is identified by model numbers TB-0520IC and UDI: 04953170308581. The product was distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
Key Facts
- Adverse events reported
- Stop use 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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