Micro-Tech Usa: Medical Device Recall in 2020 - (Recall #: Z-0470-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.

Product Classification:

Class II

Date Initiated: October 5, 2020

Date Posted: November 25, 2020

Recall Number: Z-0470-2021

Event ID: 86608

Reason for Recall:

FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US.

Status: Terminated

Product Quantity: 2420 pieces

Code Information:

Lots M190808231 M191018231 M191224231 M200305232

Distribution Pattern:

US Nationwide distribution including in the states of AZ, CA, CO, CT, IL, MA, MI, NY, OH, PR, TX, VA. No OUS distribution.

Voluntary or Mandated:

Voluntary: Firm initiated