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-0535FC, UDI: 04953170337574, 04953170464959, 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 used in surgical procedures to provide cutting and coagulation functions. It is popular among healthcare providers for its efficiency and effectiveness in surgeries.
Why This Is Dangerous
Reports of adverse events indicate potential safety issues with the device's functionality, which may compromise patient safety during procedures.
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 health risks, making it critical to stop using the device immediately.
Practical Guidance
How to identify if yours is affected
- Check your inventory for the Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip.
- Verify the model number: TB-0535FC.
- Ensure the device is not used in any ongoing or future surgical procedures.
Where to find product info
The model number and UDI can typically be found on the device packaging or the device itself.
What timeline to expect
Refund processing and replacement timelines may take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all correspondence with Olympus Corporation.
- Reach out to the FDA for assistance if the company does not respond.
How to prevent similar issues
- Look for devices with safety certifications like UL or ISO.
- Research the manufacturer's history of recalls before purchasing similar devices.
- Consult with healthcare professionals regarding the safety of surgical instruments.
Documentation advice
Keep records of any communication with Olympus and document any instances of adverse events for future reference.
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Product Details
The recalled product is the Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip, Model No. TB-0535FC. It has been distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan. The recall affects all lots.
Key Facts
- Recalled product: Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
- Recall date: October 22, 2025
- Classification: Class II
- Affected regions: Worldwide, including the US
- Immediate action required: Stop using the device
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Safety Guide
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