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 Recalled by AURIS HEALTH INC Due to Reports of aspirating biopsy needle breakage

Date: April 19, 2019
Company: AURIS HEALTH INC
Status: Terminated
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, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

Quantity: 158

Why Was This Recalled?

Reports of aspirating biopsy needle breakage

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