Recall Z-0025-2020— AURIS HEALTH INC

Name: FDA recall Z-0025-2020
Creator: U.S. Food and Drug Administration
Published: 2019-04-19

Class II · Terminated

Class II FDA medical device recall by AURIS HEALTH INC, initiated 2019-04-19, terminated 2022-01-19. It names one FDA 510(k) clearance: K173760. Product: Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120. Reason: Reports of aspirating biopsy needle breakage.

Recalling firm: AURIS HEALTH INC
Classification: Class II
Status: Terminated
Initiated: 2019-04-19
Terminated: 2022-01-19
Firm location: Redwood City, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K173760 — Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc.·cleared 2018-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Reports of aspirating biopsy needle breakage

Data sourced from openFDA. This site is unofficial and independent of the FDA.