Micro-Tech Elastic Traction Device Recall: FDA Classification Issue
Micro-Tech recalls Elastic Traction Devices (11mm Lower) due to FDA classification requirements. The device requires 510(k) clearance for US market but was not appropriately classified as Class I.
Lower-risk 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.
Contact the company
What happened, in plain English
Micro-Tech is recalling Elastic Traction Devices (11mm Lower) because the FDA has determined they should be classified as a Class I device requiring 51:0(k) clearance for US marketing. This recall does not involve immediate safety risks but addresses regulatory compliance. Read more at govinfonow.com/recall/64119-micro-tech-elastic-traction-device-recall-fda-classification-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/64119-micro-tech-elastic-traction-device-recall-fda-classification-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0470-2021
Cite this page
“Micro-Tech Elastic Traction Device Recall: FDA Classification Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64119-micro-tech-elastic-traction-device-recall-fda-classification-issue. Based on FDA recall #Z-0470-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0470-2021%22&limit=1).
Why it’s dangerous
The Elastic Traction Device was not appropriately classified by the FDA as a Class I medical device. This means it requires 510(k) clearance for US marketing but was not properly classified, potentially leading to regulatory non-compliance.
Who’s affected
Users of the Elastic Traction Device for flexible endoscopy procedures are affected. Medical professionals using the device for gastrointestinal procedures are most at risk due to regulatory requirements.
How to tell if you have this one
Check for the product name 'Elastic Traction Device, 11mm Lower' with reference numbers ETD-D-26-235-C-N. The device was sold with lot numbers M190808231, M191018231, M191224231, and M200305232.
- Brand
Micro-Tech- Category
Medical device
What to do — step by step
Check Product Details
Identify the device using the reference number ETD-D-26-235-C-N and lot numbers M190808231, M191018231, M191224231, or M200305232.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 11 states.
FDA distribution: “US Nationwide distribution including in the states of AZ, CA, CO, CT, IL, MA, MI, NY, OH, PR, TX, VA. No OUS distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Connecticut, Illinois, Massachusetts, Michigan, New York, Ohio, Puerto Rico, Texas, Virginia.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this device?
The recall does not require immediate action but you should check the product details to confirm if it is affected.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0470-2021 (October 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0470-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.