September 29, 2025 | Washington, D.C. — Olympus Corporation has announced a voluntary global recall of specific lots of its ViziShot 2 FLEX (19G) EBUS-TBNA needles, after receiving multiple reports of component detachment during use, including one fatal case. The needles, a standard tool in interventional pulmonology and thoracic oncology workflows, are being recalled due to safety concerns that may result in serious patient harm, including retained foreign bodies in the airway.
The recall, posted by the U.S. Food and Drug Administration on September 22, affects products manufactured prior to May 12, 2025. Olympus has also confirmed that the incident involves detachment of the hypotube stabilizer sheath, a critical part that may fail during use and result in non-radiopaque plastic components being unintentionally left in the patient.
The ViziShot 2 FLEX (19G) is widely used in endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) — a common, minimally invasive procedure for evaluating lung lesions, sampling mediastinal lymph nodes, and staging lung cancer. Olympus is one of the leading global suppliers of EBUS instruments, and the 19G variant is favored in certain biopsy contexts for its balance of flexibility and needle gauge.
According to the FDA safety alert and Olympus’ own documentation, the recall stems from identified risks where the needle sheath or hypotube can become dislodged if the sheath is damaged during insertion, manufacturing, or routine use. Olympus received complaints involving compromised devices, including one where a plastic component was left inside a patient’s airway, resulting in a reported death.
The primary issue is that these small plastic components are not visible on X-ray, making it difficult to confirm their location or removal during or after procedures. In certain cases, patients required bronchoscopic or surgical interventions to retrieve the retained components.
Olympus acknowledged that a key failure point in their production system involved manual visual inspections, which failed to detect compromised sheaths. In response, the company has now implemented automated inspection systems designed to more reliably identify defects in future manufacturing batches.
What Does This Mean for Surgical and Pulmonary Providers?
This recall raises urgent concerns for interventional pulmonologists, thoracic surgeons, operating room staff, and supply chain professionals. The ViziShot 2 FLEX is a routine tool in multiple hospital systems across the United States. Any interruptions in its availability or doubts about its reliability can directly disrupt procedure scheduling, especially in oncology cases where time-sensitive diagnostics are crucial.
Additionally, the issue highlights a broader vulnerability: small-diameter surgical instruments, which rely on precision manufacturing, carry increased risks when QA processes falter. In the case of EBUS-TBNA needles, even minor component failures can have life-threatening consequences given the device’s direct access to the airway and vascular-adjacent tissues.
The recall does not affect all EBUS-TBNA needles manufactured by Olympus. Other needle models remain in circulation and are considered safe. However, this event may prompt purchasing departments to reevaluate vendor diversity, and surgeons may begin requesting alternative devices for high-risk patients.
Hospitals and surgical centers must take immediate action to:
1. Identify and quarantine affected lots.
2. Verify procurement history to determine if recalled devices were used in recent procedures.
3. Communicate with Olympus and clinical staff about ongoing availability of replacement devices.
4. Consider alternative vendors or models to maintain procedural continuity.
The FDA has not issued a market-wide stop-use notice beyond the affected lots, but clinical stakeholders are advised to maintain heightened vigilance and monitor patients who underwent EBUS procedures recently.
Some procurement teams are also using this event to audit inspection standards across other device lines, especially those used in airway, cardiac, or endoscopic procedures.
Clinical Risk and Patient Management
Providers who recently used the recalled needles should monitor patients for signs of:
• Persistent cough or chest discomfort
• Fever or infection (suggesting retained foreign body)
• Unexpected clinical complications post-biopsy
