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-0535PC, UDI: 04953170308659, 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 used in various medical procedures, valued for its precision and efficiency. Healthcare providers utilize it in operating rooms for cutting and coagulating tissue.
Why This Is Dangerous
The recall indicates ongoing safety concerns related to adverse events that could potentially harm patients during medical procedures. Users must cease usage to avoid risks of injury.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall could disrupt surgical operations where the Thunderbeat is utilized, causing potential delays and requiring alternative surgical instruments.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device to confirm if it is TB-0535PC.
- Review any recall notifications received via mail from Olympus.
- Consult with your healthcare provider for professional insight on the recall.
Where to find product info
The model number can typically be found on the device's packaging or on the device itself, often near the serial number label.
What timeline to expect
Expect to receive instructions and a potential refund processing time of 4-6 weeks after contacting Olympus.
If the manufacturer is unresponsive
- Follow up with Olympus Corporation if you do not receive a response within a week.
- Document all correspondence attempts for your records.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Look for safety certifications when purchasing medical equipment.
- Regularly consult with healthcare providers about device safety updates.
Documentation advice
Keep records of your purchase, including receipts and correspondence with Olympus for future reference.
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Product Details
The recalled product is the Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip, Model No. TB-0535PC. It distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
Key Facts
- Recall date: October 22, 2025
- Quantity recalled: 3,381 units
- Distribution: Worldwide, including the US
- Reported incidents: Adverse events
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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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