Olympus Corporation has expanded its voluntary recall of ViziShot 2 FLEX (19G) EBUS-TBNA needles following reports that device components have ejected or detached during medical procedures, the Food and Drug Administration announced Thursday.

The expanded recall, announced from the company's Center Valley, Pennsylvania headquarters on January 16, 2026, affects the ViziShot 2 FLEX endobronchial ultrasound-guided transbronchial needle aspiration devices used in diagnostic procedures. The action represents an escalation of a previous global medical device removal that Olympus had already initiated.

According to the FDA recall notice, Olympus received and investigated multiple complaints regarding component failures during the use of these specialized medical needles. The reported malfunctions involve critical device components that eject or detach unexpectedly while healthcare providers are performing procedures on patients.

The ViziShot 2 FLEX needles are medical devices used in endobronchial ultrasound-guided transbronchial needle aspiration procedures, commonly referred to as EBUS-TBNA. These procedures allow physicians to obtain tissue samples from lymph nodes and masses in the chest area through a minimally invasive approach. The 19-gauge needles are inserted through a bronchoscope to collect samples for diagnostic purposes, particularly in cases involving suspected lung cancer or other pulmonary conditions.

Component ejection or detachment during these procedures poses serious safety risks to patients. When needle components separate unexpectedly, they can potentially remain inside the patient's body, requiring additional medical intervention to remove them. This type of device failure can also compromise the diagnostic procedure itself, potentially requiring patients to undergo repeat testing.

The recall expansion indicates that the initial scope of the device removal was insufficient to address the full extent of the safety concerns. Medical device recalls typically begin with specific lot numbers or manufacturing dates, but can be expanded when additional affected products are identified or when the scope of the problem becomes clearer through ongoing investigation.

Olympus Corporation, a Japanese multinational manufacturer of optical and digital precision technology, has faced regulatory scrutiny in recent years regarding the safety of various medical devices. The company's decision to voluntarily expand this recall demonstrates cooperation with FDA oversight, though it also highlights ongoing quality control challenges in medical device manufacturing.

The FDA classifies medical device recalls based on the level of health risk they pose. While the specific classification level for this expanded recall has not been disclosed in the available information, component ejection during invasive procedures typically warrants serious regulatory attention due to the potential for patient harm.

Healthcare facilities that have purchased ViziShot 2 FLEX devices are expected to receive detailed instructions from Olympus regarding the recall process. This typically includes guidance on identifying affected devices, removing them from use, and returning them to the manufacturer. Hospitals and clinics may also need to notify patients who underwent procedures with the recalled devices, depending on the specific circumstances and timing of their use.

The medical device industry has faced increased scrutiny from regulators in recent years following high-profile recalls and safety issues. The FDA has strengthened its oversight of device manufacturing and post-market surveillance, requiring companies to report adverse events more promptly and thoroughly investigate safety concerns.

For patients who have undergone EBUS-TBNA procedures using ViziShot 2 FLEX needles, healthcare providers will likely conduct individual risk assessments. While component ejection is a serious concern, not all patients who had procedures with these devices will necessarily experience complications. Medical professionals will evaluate each case based on factors such as when the procedure was performed and whether any symptoms suggest device-related issues.

The expanded recall underscores the importance of robust post-market surveillance for medical devices. Even after receiving regulatory approval, medical devices continue to be monitored for safety issues that may not have been apparent during initial testing. Healthcare providers and device manufacturers are required to report adverse events to the FDA, which can lead to recalls when patterns of safety concerns emerge.

Olympus has not indicated when a corrected version of the ViziShot 2 FLEX device might become available. In the meantime, healthcare providers performing EBUS-TBNA procedures will need to use alternative devices or modify their approaches to ensure patient safety while maintaining access to necessary diagnostic services.

The recall highlights the complex balance between medical innovation and patient safety in the medical device industry. As manufacturers develop increasingly sophisticated diagnostic tools, ensuring their reliability under real-world clinical conditions remains a critical challenge that requires ongoing vigilance from both companies and regulators.