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 Devices
- Model numbers
- Lot Code: Model: TB-0520FC, UDI: 04953170370519, 04953170370502, 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 5 mm, 20 cm, Front-Actuated Grip is a surgical device used in various medical procedures. It is designed to provide precision in surgical applications and is commonly used by healthcare professionals in operating rooms.
Why This Is Dangerous
The device has been linked to ongoing adverse events, which raises concerns about its safety and efficacy in medical procedures. Users must stop using it immediately to avoid potential health risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers and patients who rely on the device for surgical procedures. Immediate cessation of use is essential to prevent possible health complications.
Practical Guidance
How to identify if yours is affected
- Check the model number and lot code on your device against the recall details.
- Contact Olympus Corporation of the Americas for confirmation if needed.
- Refer to the recall notification letter for specific identification instructions.
Where to find product info
The model number and lot codes are typically located on the device packaging or the device itself, usually near the manufacturer's label.
What timeline to expect
Expect a refund or replacement processing timeline of approximately 4-6 weeks after your request is submitted.
If the manufacturer is unresponsive
- Contact Olympus customer service again for follow-up.
- Document all communication attempts in case further action is needed.
- Consider reaching out to consumer protection agencies if no response is received.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Look for safety certifications when purchasing medical equipment.
- Stay informed about product safety updates in the healthcare sector.
Documentation advice
Keep a record of your purchase receipt, correspondence with Olympus, and any returned items as proof of the recall.
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Product Details
The recalled product is the Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip, with model number TB-0520FC. It has a Unique Device Identifier (UDI) of 04953170370519 and additional UDI of 04953170370502. The device was distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
Key Facts
- Recalled model: Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
- Recall date: October 22, 2025
- Adverse events reported but specifics not disclosed
- Patients instructed to stop use immediately
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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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