FDA Device recall Z-0470-2021
Elastic Traction Device, 11mm Lower
- FDA Device
- Class II
- terminated
- Published 2020-11-25
On 2020-11-25 the FDA classified a Class II recall of Elastic Traction Device, 11mm Lower by Micro Tech Usa, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0470-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-05 |
| Published | 2020-11-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Micro Tech Usa |
| Distribution | US |
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.
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.
Identifiers
| code_info | Lots M190808231 M191018231 M191224231 M200305232 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0470-2021%22
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