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-0510IC, UDI: 04953170308734, All Units.
- 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, 10 cm, Inline Grip is a surgical device used in various medical procedures. Surgeons typically choose this device for its ability to efficiently cut and coagulate tissue during operations.
Why This Is Dangerous
This recall involves potential risks from adverse events related to the device's functionality. The nature of these events suggests that continued use could lead to serious complications during surgical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses significant safety concerns for healthcare providers and patients. Immediate action is necessary to prevent potential adverse events during surgical procedures.
Practical Guidance
How to identify if yours is affected
- Check the model number on your device for TB-0510IC or UDI 04953170308734.
- If you find these identifiers, your device is recalled.
- Contact Olympus for detailed recall instructions.
Where to find product info
Model numbers are typically located on the packaging or the device itself. For surgical instruments, check near the handle or base.
What timeline to expect
Expect 4-6 weeks for refund processing after returning the device.
If the manufacturer is unresponsive
- Document all communications with Olympus regarding the recall.
- Reach out to regulatory bodies like the FDA for assistance.
How to prevent similar issues
- Look for FDA recalls before purchasing medical devices.
- Verify that the product has current safety certifications before use.
Documentation advice
Keep records of your purchase, communications regarding the recall, and any medical reports related to the device's use.
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Product Details
The Olympus Thunderbeat 5 mm, 10 cm, Inline Grip has Model No. TB-0510IC and UDI 04953170308734. The product was distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
Key Facts
- Recall initiated on October 22, 2025
- Distributed in the US and five other countries
- Class II recall indicates moderate to high risk
- Stop using the device 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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