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-0545IC, UDI: 04953170308673, 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 minimally invasive procedures. Healthcare professionals purchase it for its advanced capabilities in cutting and coagulation.
Why This Is Dangerous
The hazard arises from adverse events which could potentially lead to complications during surgical procedures. Users must cease use to mitigate any risks associated with these incidents.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must halt usage of this device, which may cause disruptions in surgical schedules and patient care.
Practical Guidance
How to identify if yours is affected
- Check your device for model number TB-0545IC.
- Verify if your device has the UDI number 04953170308673.
- Contact your healthcare provider if unsure about your device.
Where to find product info
Model and UDI numbers can typically be found on the packaging or directly on the device.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks after returning the device.
If the manufacturer is unresponsive
- Contact customer service again for follow-up.
- Document all communications regarding the return.
- Consider filing a complaint with regulatory authorities if unresponsive.
How to prevent similar issues
- Look for devices with updated safety certifications.
- Research product reviews for adverse event reports before purchase.
- Consult with healthcare professionals about device safety.
Documentation advice
Keep copies of any receipts and correspondence with Olympus regarding the recall as part of your records.
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Product Details
The recalled product is the Olympus Thunderbeat, 5 mm, 45 cm Inline Grip, Model No. TB-0545IC. The device has a Unique Device Identifier (UDI) of 04953170308673. The recall affects all lots.
Key Facts
- Recall date: October 22, 2025
- Quantity recalled: 30 units
- Affected regions: Worldwide including the US and Canada
- Immediate action required for users
- Reports of adverse events noted
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Safety Guide
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