Facility

NEOTRACT, INC.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3005791775
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	4155 HOPYARD ROAD Pleasanton, CA, US 94588
Registration status	Active · expires 2026
Parent company	NEOTRACT, INC. (owner-operator 9088740)
Brand names	UroLift System UL400

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Implantable Transprostatic Tissue Retractor System
Product code PEW (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5530

Recalls & enforcement

Class IIOngoing2022-06-24
There is the potential that during implant deployment, the device may not properly deliver a implant.
Class IITerminated2018-07-06
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 …

FDA inspections (1)

NAI2016-06-08
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by NEOTRACT, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NEOTRACT, INC. (FEI 3005791775) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005791775-neotract-inc/

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