Neotract Inc: Medical Device Recall in 2022 - (Recall #: Z-1502-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool

Product Classification:

Class II

Date Initiated: June 24, 2022

Date Posted: August 10, 2022

Recall Number: Z-1502-2022

Event ID: 90548

Reason for Recall:

There is the potential that during implant deployment, the device may not properly deliver a implant.

Status: Ongoing

Product Quantity: 18,722 systems

Code Information:

UDI/DI: 00814932020049 & 00814932020001; Lot #s: 73M2100393 73A2200670 73M2100394 73A2200671 73M2100395 73A2200672 73A2200012 73A2200673 73A2200013 73A2200674 73A2200014 73A2200832 73A2200221 73A2200841 73A2200222 73A2200859 73A2200223 73A2200905 73A2200224 73B2200116 73A2200225 73B2200466 73A2200226 73C2200567 73A2200473 New Lots added as of 08/01/2022: 73A2200834, 73C2200911, and 73C2201163

Distribution Pattern:

US: AK AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NY OH OK PA RI SC SD TN TX UT VA VT WI WV OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated