# Major Recall Alert: ViziShot 2 FLEX (19G) EBUS -TBNA Needles Recalled Due to Device & Drug Safety - Defect
Olympus Corporation has issued an urgent expansion of its previously announced recall of the **ViziShot 2 FLEX (19G) EBUS-TBNA needles**, a widely-used medical device for fine needle aspiration and biopsy procedures, after reports of severe adverse events, including one confirmed death. The recall underscores the company's commitment to patient safety and aims to mitigate potential harm caused by defective components.
Learn more about the recall, its risks, and the immediate steps you should take below.
## Why This Recall is Important
Medical device recalls have far-reaching implications, especially when complications involve patient safety. The **ViziShot 2 FLEX (19G)** is used during critical biopsy procedures of the **tracheobronchial tree**, making its reliability essential.
The recall was prompted by specific reports of **device components ejecting or detaching** during clinical use. These defective operations pose serious risks, such as:
- **Unintended detached device components in the airway**
- **Potentially requiring bronchoscopic extraction or surgical removal**
- Adverse events, including **patient injury** and **fatalities**
This update is particularly significant because it **supersedes the August 2025 recall**, which only involved certain lots. Olympus has now **expanded the recall to include **all lots of the ViziShot 2 FLEX devices** after further evaluations revealed additional defects.
## Details of the Recall
**Announced By:** Olympus Corporation
**Category:** Device & Drug Safety – Defect
**Product Involved:** ViziShot 2 FLEX (19G) EBUS-TBNA needles
**Recall Date:** January 16, 2026
**Reason for Recall:**
- Device components can detach or eject, causing patient injury.
- Additional issues identified, such as **heat-shrink material degradation** and **use errors**, affecting all device lots.
### Key Concerns Associated With the Defective Device:
- Impaired needle deployment or retraction
- Fluid leakage
- Difficulty in sample collection
- Heat-shrink degradation leading to **debris in tracheobronchial regions**
Other similar products, including alternative EBUS-TBNA needles, **are not affected** by this recall.
For further details, visit the [official FDA safety recall page here](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-expands-voluntary-recall-vizishot-2-flex-19g-ebus-tbna-needles).
## What You Should Do
If you are a healthcare provider or facility using **ViziShot 2 FLEX (19G) needles**, Olympus strongly advises the following steps:
1. **Cease using the product immediately.**
2. **Quarantine all affected devices** to prevent further usage.
3. Return items to Olympus following the instructions provided in the recall communication.
### Reporting Adverse Events
If your facility has experienced adverse reactions or safety concerns with this product, report the issue to the **FDA’s MedWatch Safety Information and Adverse Event Reporting Program**:
👉 Online Form: [Submit to MedWatch](https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda)
### Customer Service Support
For identifying affected products or responding to this recall, contact **Olympus Technical Assistance Center (TAC):**
- **Phone**: 1-800-848-9024 (Option 1)
- **Hours**: Monday-Friday, 7 AM - 8 PM ET
- **Email**: complaints@olympus.com
Your swift action is critical to ensure patient safety.
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### Stay Informed and Protected
📲 **[Download the Recall Alert App Now](#)**
For ongoing updates and official recall information, refer to the [FDA recall announcement here](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-expands-voluntary-recall-vizishot-2-flex-19g-ebus-tbna-needles).
Stay vigilant, and prioritize safety as we work to spread awareness of critical manufacturing defects affecting medical devices.