AURIS HEALTH INC: Medical Device Recall in 2019 - (Recall #: Z-0025-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

Product Classification:

Class II

Date Initiated: April 19, 2019

Date Posted: November 27, 2019

Recall Number: Z-0025-2020

Event ID: 82763

Reason for Recall:

Reports of aspirating biopsy needle breakage

Status: Terminated

Product Quantity: 158

Code Information:

Lots: RS181129-1 RS181129-2 RS181210-1 RS181210-2 RS181210-3 RS181210-4 RS190117-1 RS190125-1 RS190211-1 RS190225-3 RS190308-1 RS190319-1

Distribution Pattern:

US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.

Voluntary or Mandated:

Voluntary: Firm initiated