Reported Jan 29, 2025 · Ongoing

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm,…

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

Brand NameOlympus Thunderbeat Front-Actuated Grip
Type S Hand Instrument Product Name
- THUNDERBEAT 5 mm
- 35 cm
Front-actuated Grip Type S Model NumberTB-0535FCS
Catalog Number/Product CodeR5000687
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: Model NumberTB-0535FCS
Catalog Number/Product CodeR5000687
UDI04953170409677 and 04953170383540
LotsAll
Amount recalled: 495,865 units (96,253 US, 399,612 OUS)

The agency filed one notice per product. You are reading one of them; the other 10 are below.

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.

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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109 in total.