Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System Recalled by Neotract Inc Due to Upon implant deployment, the Capsular Tab may not...
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 Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
Quantity: 8,804
Why Was This Recalled?
Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant behind. Failure to deliver a capsular tab may result in a delay in completing a treatment or an inability to complete a treatment for the patient. Use of a recalled device may lead to increased frequency of exiting known risks associated with the product, including bleeding and tissue trauma associated with delivering the needle.
Where Was This Sold?
This product was distributed to 44 states: AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI
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