Approximately 95,430 BioPince Ultra and Tru-Core II Biopsy Instruments are being recalled because holes were found in the packaging trays. These holes compromise the sterile barrier necessary for medical procedures, which could allow bacteria or other microorganisms to contaminate the device. Argon Medical Devices, Inc. initiated this voluntary recall after identifying the defect which affects various models and lot numbers distributed worldwide.
Using a non-sterile biopsy instrument can introduce microorganisms directly into the patient's body at the access site. This poses a significant risk of causing serious infections, such as bacteremia (bacteria in the blood) or sepsis, which is a life-threatening response to infection.
Quarantine and contact manufacturer
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
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