Facility

UROMEDICA, 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)	3003477176
Establishment type	Manufacture Medical Device
Location	1840 Berkshire Ln N PLYMOUTH, MN, US 55441
Registration status	Active · expires 2026
Parent company	UROMEDICA, INC. (owner-operator 9047760)
Brand names	ProACT Adjustable Continence Therapy for Men; ProACT Tissue Expanding Device II; ProACT Implantation Instrument Set; ProACT Blunt Trocar

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Device, Incontinence, Mechanical/Hydraulic
Product code EZY (opens in a new tab) · Class III · Gastroenterology, Urology · 21 CFR 876.5280

Recalls & enforcement

Class IITerminated2021-11-22
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Class IITerminated2019-04-10
Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.

FDA inspections (1)

NAI2017-01-11
No Action Indicated · Compliance: Devices; Project Evaluation: 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 UROMEDICA, 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. “UROMEDICA, INC. (FEI 3003477176) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003477176-uromedica-inc/

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