Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
UroLift System REF UL400-4 Recalled by Neotract Inc Due to There is the potential that during implant deployment,...
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 Neotract Inc directly.
Affected Products
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Quantity: 18,722 systems
Why Was This Recalled?
There is the potential that during implant deployment, the device may not properly deliver a implant.
Where Was This Sold?
This product was distributed to 45 states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, PA, RI, SC, SD, TN, TX, UT, VT, VA, WV, WI, DC
About Neotract Inc
Neotract Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report