Monarch Medical Technologies: Medical Device Recall in 2019 - (Recall #: Z-0354-2020)

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:

EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)

Product Classification:

Class II

Date Initiated: October 1, 2019

Date Posted: November 20, 2019

Recall Number: Z-0354-2020

Event ID: 83926

Reason for Recall:

Product was distributed prior to approval or clearance from FDA.

Status: Terminated

Product Quantity: 6 units

Code Information:

versions: v 1.7.1, 1.7.4, 1.7.5

Distribution Pattern:

SC, IL IN, CA

Voluntary or Mandated:

Voluntary: Firm initiated