Recall Z-0354-2020— Monarch Medical Technologies

Name: FDA recall Z-0354-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-01

Class II · Terminated

Class II FDA medical device recall by Monarch Medical Technologies, initiated 2019-10-01, terminated 2026-02-10. FDA's recall record names no specific 510(k) clearance for this event. Product: EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5). Reason: Product was distributed prior to approval or clearance from FDA..

Recalling firm: Monarch Medical Technologies
Classification: Class II
Status: Terminated
Initiated: 2019-10-01
Terminated: 2026-02-10
Firm location: Charlotte, NC, United States

Product description

EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)

Reason for recall

Product was distributed prior to approval or clearance from FDA.

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