Olympus Corporation of the Americas is recalling 5,045 units of its Thunderbeat II Shears because a component at the tip of the device may detach during surgical use. This recall affects four different lengths of the 5mm shears with ultrasonic mode, all of which are manufactured in the United States. While no injuries have been reported to date, the potential for a device component to break off inside a patient during surgery poses a significant safety concern.
The distal tip of the shears can detach during use, which could leave a foreign object inside a patient's body or cause unintended tissue damage during a procedure.
Recalled due to potential for detachment of distal tip component.
Recalled due to potential for detachment of distal tip component.
Recalled due to potential for detachment of distal tip component.
Recalled due to potential for detachment of distal tip component.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.