Which Olympus ViziShot 2 FLEX 19G product is being recalled?

All lots of the Olympus ViziShot 2 FLEX 19G EBUS-TBNA needle are recalled.

Why are the Olympus ViziShot 2 FLEX needles being removed from use?

The heat-shrink sleeve that secures the needle can fail, letting parts detach inside the airway.

Do specific lot numbers of Olympus ViziShot 2 FLEX 19G needles carry higher risk?

No, Olympus expanded the recall to cover every lot produced.

What should facilities do with recalled Olympus ViziShot 2 FLEX needles?

Stop using, quarantine, and return the needles per Olympus instructions.

Have any injuries or deaths been linked to the Olympus ViziShot 2 FLEX 19G recall?

Yes. Multiple injuries and one death have been reported.

FDA Recall: Olympus ViziShot 2 FLEX (19G)

Source: FDA

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FDA Recall: Olympus ViziShot 2 FLEX (19G)

Olympus • January 16, 2026

Olympus ViziShot 2 FLEX 19G Needle Recall Over Component-Detachment Hazard

Published: January 16, 2026 | Recall Classification: Voluntary device removal

Olympus Corporation has recalled every lot of its ViziShot 2 FLEX 19G EBUS-TBNA biopsy needle because internal components can dislodge during bronchoscopy. The malfunction has already caused multiple patient injuries and one confirmed death. Clinicians should stop using and immediately quarantine all affected inventory.

Why Olympus ViziShot 2 FLEX 19G Needles Were Recalled

Component detachment: Degradation of the heat-shrink sleeve that secures the needle hub can let metal or plastic fragments separate inside the airway.
Patient harm: Detached fragments may embed in lung tissue, trigger bleeding, or block the airway, sometimes requiring emergency surgery.
Documented events: Several injuries and one fatality have been linked to the defect, prompting an expansion of the limited August 2025 recall.
All-lot scope: Olympus concluded the failure mode exists in every production lot, so 100 % of ViziShot 2 FLEX 19G needles are now recalled.

Sources

FDA Recall Announcement

Recalled Products and Lot Numbers

The action applies to all Olympus ViziShot 2 FLEX (19G) EBUS-TBNA needles, regardless of lot code, packaging date, or distribution channel. No other Olympus EBUS-TBNA models are affected.

Required Actions for Healthcare Facilities

Stop using Olympus ViziShot 2 FLEX 19G needles immediately.
Isolate and label all stock to prevent accidental use.
Arrange product return per the Olympus recall notice.
Report any adverse events to FDA MedWatch (online form).
Contact the Olympus Technical Assistance Center at 1-800-848-9024 (Option 1) or complaints@olympus.com with questions about identification, replacement, or reimbursement.

Health Risks of Continued Use

If a component breaks loose inside the tracheobronchial tree, patients may experience:

Airway obstruction or hemorrhage
Emergency bronchoscopic retrieval procedures
Thoracic surgery when endoscopic removal fails
Prolonged hospitalization, infection, or death

Olympus ViziShot 2 FLEX 19G Recall – Frequently Asked Questions

Which Olympus ViziShot 2 FLEX 19G product is being recalled?: All lots of the Olympus ViziShot 2 FLEX 19G EBUS-TBNA needle, a device used to collect lymph-node tissue samples during bronchoscopy.
Why are the Olympus ViziShot 2 FLEX needles being removed from use?: Olympus determined that the heat-shrink material can fail, allowing needle components to detach and enter the patient’s airway, posing life-threatening risks.
Do specific lot numbers of Olympus ViziShot 2 FLEX 19G needles carry higher risk?: No. Olympus concluded the defect is present across every lot produced to date, so the recall includes 100 % of inventory.
What should facilities do with recalled Olympus ViziShot 2 FLEX needles?: Immediately quarantine the needles and follow Olympus’s return instructions for credit or replacement.
Have any injuries or deaths been linked to the Olympus ViziShot 2 FLEX 19G recall?: Yes. Olympus has confirmed multiple injury reports and one patient death associated with component detachment.
How can I obtain a refund or replacement for Olympus ViziShot 2 FLEX 19G inventory?: Contact Olympus TAC at 1-800-848-9024 (Option 1) or email complaints@olympus.com to arrange return authorization and reimbursement.