Micro-Tech Elastic Traction Device Recalled for Regulatory Classification Issues
Micro-Tech USA is recalling Elastic Traction Devices because they are not appropriately classified as Class I and require 510(k) clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a regulatory classification and clearance issue (documentation/regulatory compliance) rather than a reported safety hazard, injury, or defect causing harm, which aligns with the 'Low' severity criteria for documentation issues.
Plain-English summary
Micro-Tech USA is recalling the Elastic Traction Device, 11mm Lower (UPN: ER56041, Reference Number: ETD-D-26-235-C-N). The product is indicated for use in flexible endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.
The recall was initiated because the FDA informed Micro-Tech that the device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US. This is a regulatory compliance issue regarding the device's classification and marketing authorization.
The recall affects 2,420 pieces distributed nationwide in the US, including in Arizona, California, Colorado, Connecticut, Illinois, Massachusetts, Michigan, New York, Ohio, Puerto Rico, Texas, and Virginia. There is no distribution outside the US. Affected lots include M190808231, M191018231, M191224231, and M200305232. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate action, as the issue is regulatory rather than a direct safety hazard.
The recalled product
- 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.
- Manufacturer
- Micro-Tech Usa
- Category
- Medical Device — Endoscopy
- Affected units
- 2,420
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots M190808231 M191018231 M191224231 M200305232
Distribution
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