Reported Apr 29, 2026 · Ongoing
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm
- Model NumberTB2-0535FC
- Lot codes and dates
- Model NumberTB2-0535FC
- UDI-DI04953170440014. All Lot Numbers
- Amount recalled
- 3,360 units
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Why it was recalled
Potential for detachment of a distal tip component of the device during use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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