Facility

PARAGONIX TECHNOLOGIES, INC.

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

FDA Establishment Identifier (FEI)	3011175555
Establishment type	Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	950 Winter Street, North Waltham, MA, US 02451
Registration status	Active · expires 2026
Parent company	Paragonix Technologies (owner-operator 10057453)
Brand names	BAROguard

Devices registered here (1)

System, Perfusion, Kidney
Product code KDN (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5880

Recalls & enforcement

Class IIOngoing2026-07-20
Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.

FDA inspections (2)

VAI2022-11-03
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-12-18
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 2026-09-07. The dashboard profile can take several seconds to load.

All facilities operated by Paragonix Technologies

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-09-07. Verify this facility record at FDA → (opens in a new tab)

Watch PARAGONIX TECHNOLOGIES, INC.

We'll email you when a new FDA recall, enforcement, inspection classification, or warning letter is published for a facility you follow.

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.