Class II — Potential Health Hazard

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

Monarch Platform (Endoscopy) Recalled by AURIS HEALTH INC Due to Endoscopy/bronchoscopy/urology devices may have a strain relief defect...

Date: August 2, 2024
Company: AURIS HEALTH INC
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 AURIS HEALTH INC directly.

Affected Products

Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.

Quantity: 176

Why Was This Recalled?

Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About AURIS HEALTH INC

AURIS HEALTH INC has 6 total recalls tracked by RecallDetector.

Related Recalls

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