Facility

LABORIE MEDICAL TECHNOLOGIES CORP.

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

Key facts

2recalls · worst Class II

2inspections · 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)	3017448360
Establishment type	Manufacture Medical Device
Location	180 International Drive Portsmouth, NH, US 03801
Registration status	Active · expires 2026
Parent company	Laborie Medical Technologies Corp. (owner-operator 10079684)
Brand names	Urocap V; Urocap III; Urocap IV; Urocap IV Light; Urocap NXT

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Uroflowmeter
Product code EXY (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1800

Recalls & enforcement

Class IIOngoing2026-05-21
Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressu…
Class IITerminated2019-07-17
Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard

FDA inspections (2)

NAI2020-02-26
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2016-02-22
No Action Indicated · Compliance: 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 Laborie Medical Technologies Corp.

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. “LABORIE MEDICAL TECHNOLOGIES CORP. (FEI 3017448360) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3017448360-laborie-medical-technologies-corp/

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