The Recall Desk

Manufacturer

Neotract Inc

2 recalls in our database name Neotract Inc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2022-08-10

Of the 2 recalls from Neotract Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-1502-2022·2022-08-10

    UroLift System recalled for potential implant deployment failure

    Neotract Inc is recalling 18,722 UroLift Systems due to potential improper implant deployment during use. Patients should contact their healthcare provider.

    Product
    UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0598-2019·2018-12-19

    Neotract Recalls UroLift System Due to Capsular Tab Delivery Failure

    Neotract is recalling UroLift System devices because the capsular tab may fail to deploy, potentially delaying or preventing treatment completion.

    Product
    UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
    Category
    Medical Device
    Distribution
    44 states