Z-0470-2021Class II

Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N -

Name: Z-0470-2021 Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N -
Creator: Micro-Tech Usa
Published: 2020-10-05
License: https://open.fda.gov/license/

Micro-Tech USA Inc. / initiated 2020-10-05 / Terminated

FDA source

Micro-Tech Usa began a recall of 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... on 2020-10-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0470-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-05
Posted: 2020-11-18
Terminated: 2021-12-02
Recalling firm: Micro-Tech USA Inc.
Product: 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 code: MND Ligator, Esophageal
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.
FDA root cause: No Marketing Application
Action: On October 7, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers, advising them that the firm is voluntarily recalling the Elastic Traction Device. Further distribution or use of any remaining product should cease immediately. Customers were asked to identify and quarantine devices left in inventory. They should complete the customer Acknowledgement and Receipt Form accompanying the letter and return the form to Micro-Tech Endoscopy USA. If product is available for return, the firm will contact your facility to create a Returned Material Authorization with shipping instructions. Customers should pass the notice on to all those who need to be aware within their organization, or to any organization where the affected devices have been transferred.
Quantity in commerce: 2420 pieces
Distribution: US Nationwide distribution including in the states of AZ, CA, CO, CT, IL, MA, MI, NY, OH, PR, TX, VA. No OUS distribution.
Product codes and lots: Lots M190808231 M191018231 M191224231 M200305232

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0470-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0470-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-25	2020-11-18

Product code MND

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)