Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle Recalled by Olympus Corporation of the Americas Due to Non-conformances in Veran devices (ig4 Image Guided System,...

Date: August 10, 2023
Company: Olympus Corporation of the Americas
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.

Affected Products

Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm INS-0050 vPad Patient Tracker, 5/Bx INS-0048 vPad Connector Cable

Quantity: 60102 units

Why Was This Recalled?

Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Olympus Corporation of the Americas

Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report