Reported Jan 29, 2025 · Ongoing
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45…
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?
- Brand NameOlympus Thunderbeat Front-Actuated Grip
- Type S Hand Instrument Product Name
THUNDERBEAT 5 mm45 cm
- Front-actuated Grip Type S Model NumberTB-0545FCS
- Catalog Number/Product CodeN5423510
- Software VersionN/A
- Product DescriptionThunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400)
- Lot codes and dates
- ModelTB-0545FCS
- Catalog Number/Product CodeN5423510
- UDI
0495317038353304953170383530
- LotsAll
- Amount recalled
- 112 units (OUS ONLY)
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
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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