Olympus Corporation of the Americas is recalling 104,508 units of the ViziShot 2 FLEX Single Use Aspiration Needle (Model NA-U403SX-4019). This tissue biopsy device is being recalled because the a-traumatic tips may be deformed, which could go undetected during use. Patients and medical staff should stop using the affected devices and contact the manufacturer or their distributor to arrange for a return or replacement.
A deformed needle tip may cause unintended tissue damage or prevent the device from properly performing a biopsy, potentially leading to diagnostic errors or patient injury.
Firm initiated voluntary recall for return, replacement, or correction.
The device consists of a handle, sheath, needle, and removable stylet used for tissue biopsy.
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 · FDA Press Release (1) · FDA Press Release (2) · Raw API Response
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