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 Instrument
- Model numbers
- Model No. TB-0545FCS, UDI: 04953170383533, 04953170383526, 04953170409684, 04953170383519, 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, 45 cm, Front-Actuated Grip Type S is a surgical instrument designed for use in various medical procedures. Surgeons and healthcare providers often use it to enhance precision and efficiency during operations.
Why This Is Dangerous
The device has been linked to adverse events that may compromise patient safety. These reports prompted the recall to prevent further incidents.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers should stop using the device immediately to avoid potential health risks. The recall may cause inconvenience for healthcare providers who rely on this equipment for surgical procedures.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device against the recalled models listed in the recall notice.
- Verify the UDI numbers to confirm if your device is affected.
- Refer to the packaging or official documentation for additional identifiers.
Where to find product info
The model number and UDI can typically be found on the device label or in the user manual.
What timeline to expect
Expect refund processing to take approximately 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Contact Olympus customer service for follow-up.
- Document all communications and attempts to resolve the issue.
How to prevent similar issues
- Research alternative surgical instruments with better safety records.
- Look for devices with recent safety certifications and endorsements.
- Consult with healthcare professionals regarding the latest surgical technology advancements.
Documentation advice
Keep records of your purchase, any correspondence with Olympus, and photographs of the device as evidence.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S is a medical device used in surgical procedures. The recalled models include TB-0545FCS and several UDI numbers. The product was distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
Key Facts
- Recall Date: October 22, 2025
- Quantity: 9,542 units recalled
- Affected Models: TB-0545FCS and various UDI numbers
- Distribution: Worldwide including the US
- Classification: Class II
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.