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-0545PC, UDI: 04953170308635, 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 for various medical procedures. Healthcare providers purchase this device for its advanced features and efficiency during surgery.
Why This Is Dangerous
The defect in the device has led to adverse events that may compromise patient safety during surgical procedures. Immediate cessation of use is necessary to mitigate risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must act quickly to prevent potential adverse effects from continued use of this device.
Practical Guidance
How to identify if yours is affected
- Check if you have the Olympus Thunderbeat, Model No. TB-0545PC.
- Locate the UDI number: 04953170308635.
- Verify if the product is part of the recall using the provided FDA link.
Where to find product info
The model number and UDI can usually be found on the product packaging or the device itself.
What timeline to expect
Expect a refund processing time of 4-6 weeks after returning the device.
If the manufacturer is unresponsive
- Document all correspondence with Olympus.
- Contact the FDA if the company is unresponsive.
- Consider reaching out to consumer safety organizations.
How to prevent similar issues
- Look for FDA approval and recall history when buying medical devices.
- Ensure all medical devices are from reputable manufacturers.
- Consult healthcare providers about the safety of devices before use.
Documentation advice
Keep a record of your purchase receipt, all correspondence with Olympus, and any return shipping information.
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Product Details
The recalled product is the Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip, Model No. TB-0545PC, with UDI: 04953170308635. The recall includes all lots of this model. The product was distributed worldwide, including the United States.
Key Facts
- Recall date: October 22, 2025
- Quantity affected: 30 units
- Worldwide distribution including US, Canada, Brazil, Germany, Mexico, Japan
- High hazard level requiring immediate action
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Safety Guide
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