Quick Facts at a Glance
- Recall Date
- March 23, 2026
- Hazard Level
- HIGH
- Brand
- Olympus Corporation of the Americas
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
- Model numbers
- Model Number: TB2-0545FC. UDI-DI: 04953170440021. All Lot Numbers.
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 23, 2026
Reported by FDA DEVICE
April 29, 2026
RecallRadar source check
May 6, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for detachment of a distal tip component of the device during use.
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: E-Mail
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Full Description
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.. Reason: Potential for detachment of a distal tip component of the device during use.. Classification: Class II. Quantity: 490 units. Distribution: International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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