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-0520FCS, UDI: 04953170383571, 0495317083595, 04953170383588, 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 designed for advanced surgical procedures. Surgeons utilize this device for its capabilities in cutting and coagulating tissue efficiently.
Why This Is Dangerous
Reports indicate that the Thunderbeat device may malfunction, leading to adverse events during surgical procedures. This poses significant risks to patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers are urged to stop using the device immediately, which could disrupt scheduled medical procedures and require alternative solutions.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device.
- Check if the model number matches Model No. TB-0520FCS or any listed UDI numbers.
- If in doubt, contact Olympus for verification.
Where to find product info
The model number can typically be found on the body of the device or on the packaging.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks after contacting Olympus.
If the manufacturer is unresponsive
- Contact Olympus customer service again.
- Consider filing a complaint with the FDA if issues persist.
How to prevent similar issues
- Research the latest medical devices before purchase.
- Look for reviews from healthcare professionals.
- Ensure devices have proper certifications and clear recall histories.
Documentation advice
Keep all receipts, correspondence with Olympus, and any documentation regarding the device and recall.
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Product Details
The recall involves the Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S, Model No. TB-0520FCS. The devices were sold in multiple countries, including the US, from an unspecified date.
Key Facts
- Class II recall due to adverse events
- Products distributed worldwide
- Immediate stop-use required
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Safety Guide
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