Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Elastic Traction Device Recalled by Micro-Tech Usa Due to FDA has informed Micro-Tech that the Elastic Traction...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Micro-Tech Usa directly.
Affected Products
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.
Quantity: 2420 pieces
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Micro-Tech Usa
Micro-Tech Usa has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report