Elastic Traction Device — Class II medical device recall Z-0470-2021
Terminated recall by Micro-Tech Usa, reported 2020-11-25, distributed nationwide. FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I devi
| Recall number | Z-0470-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro-Tech Usa, Ann Arbor, MI, United States |
| Recall initiated | 2020-10-05 |
| Classified | 2020-11-18 |
| Reported by FDA | 2020-11-25 |
| Terminated | 2021-12-02 |
| Distributed | Nationwide (US) |
| Quantity | 2,420 units |
| Lot numbers | M190808231, M191018231, M191224231, M200305232 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0470-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.