FDA Medical Device Recalls (openFDA)
Micro-Tech Usa: 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.
- Recall number
- Z-0470-2021
- Recalling firm
- Micro-Tech Usa
- 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.
- Status
- Terminated
- Initiated
- 2020-10-05
- Posted
- not on file
- Terminated
- 2021-12-02
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- Lots M190808231 M191018231 M191224231 M200305232
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MND
- Firm FEI
- 3011523880
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28