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-0535FCS, UDI: 04953170383564, 04953170383557, 04953170409677, 04953170383540, 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 device is a surgical instrument used in various medical procedures. Surgeons often rely on such devices for their precision and effectiveness in cutting and coagulating tissue during surgery.
Why This Is Dangerous
The recall was initiated due to ongoing reports of adverse events, indicating potential safety risks associated with the device's use in medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the device immediately, which may disrupt scheduled surgeries and affect patient care.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device or its packaging.
- Check if your device falls under the affected model numbers listed in the recall.
- Verify the UDI associated with your device against the provided UDI numbers.
Where to find product info
Model numbers and UDI can usually be found on the device's packaging or labeling.
What timeline to expect
Expect up to 4-6 weeks for refund processing after returning the device.
If the manufacturer is unresponsive
- Contact the manufacturer again via phone or email.
- Document all communication attempts and keep records.
How to prevent similar issues
- Look for devices with up-to-date safety certifications.
- Consult with healthcare professionals about alternative devices.
- Stay informed on recalls in the medical device industry.
Documentation advice
Keep a copy of the recall notification letter, correspondence with the manufacturer, and any receipts related to your purchase.
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Product Details
The recall affects the Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S. Model numbers include TB-0535FCS, UDI: 04953170383564, 04953170383557, 04953170409677, and 04953170383540. The devices were distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
Key Facts
- Adverse events reported
- Stop using the device immediately
- Contact Olympus for instructions
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Safety Guide
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