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-0535IC, UDI: 04953170464973, 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. Healthcare providers choose this device for its advanced capabilities in tissue dissection and sealing.
Why This Is Dangerous
The device has been associated with reports of adverse events, which could pose significant risks during surgical procedures. The exact nature of these events remains unspecified but is serious enough to warrant a recall.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects both healthcare providers and patients, creating potential risks during surgeries and necessitating immediate cessation of its use.
Practical Guidance
How to identify if yours is affected
- Check the model number: TB-0535IC on your device.
- Verify the UDI: 04953170464973.
- Confirm that your device is among the recalled lots.
Where to find product info
The model number and UDI can typically be found on the device packaging or instruction manual.
What timeline to expect
Expect a refund or replacement process to take 4-8 weeks after contacting Olympus.
If the manufacturer is unresponsive
- Document all communications with Olympus regarding your recall request.
- Reach out to the FDA for further assistance if Olympus does not respond.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Consult healthcare providers about device safety history before procedures.
- Ensure devices have proper certifications and recent safety updates.
Documentation advice
Keep copies of any correspondence with Olympus, receipts, and photographs of the device for your records.
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Product Details
The Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip, Model No. TB-0535IC, is a surgical device involved in the recall. The device has a Unique Device Identifier (UDI) of 04953170464973. It was distributed worldwide, including the US and several international markets.
Key Facts
- Recall Date: October 22, 2025
- Quantity Recalled: 52 units
- Affected Regions: US, Brazil, Canada, Germany, Mexico, Japan
- Hazard Level: High
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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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