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.
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.
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.
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.
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.
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.
Identify the device using the reference number ETD-D-26-235-C-N and lot numbers M190808231, M191018231, M191224231, or M200305232.
The FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance for US marketing.
The recall does not require immediate action but you should check the product details to confirm if it is affected.
The recall addresses regulatory classification, not safety risks. There is no indication of injury risk in normal use.
We’ve drafted a message you can send Micro-Tech to request your refund or repair — edit it as you like.
Subject: Recall Z-0470-2021 — Micro-Tech Micro-Tech Hello, I own a Micro-Tech that is covered by recall Z-0470-2021 from Micro-Tech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
