Facility

Northgate Technologies Inc.

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

Key facts

6recalls · worst Class II

2inspections · worst VAI

—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)	1450997
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	1591 Scottsdale Court Elgin, IL, US 60123
Registration status	Active · expires 2026
Parent company	Northgate Technologies, Inc. (owner-operator 10092614)
Brand names	7-650-01 PUREPNEUMO Tubing Set; 7-510-52 Insufflation Tubing, Gen Use Prop Conn

Activity by year

Recalls (6)
Inspections (2)

Devices registered here (1)

Tubing/Tubing With Filter, Insufflation, Laparoscopic
Product code NKC (opens in a new tab) · Class I · Obstetrics/Gynecology · 21 CFR 884.1730

Recalls & enforcement

Class IITerminated2022-04-13
Product labeled incorrectly.
Class IIOngoing2021-10-25
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
Class IITerminated2021-01-15
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Class IITerminated2020-03-10
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Class IITerminated2017-05-24
The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. Could Delay Care.
Class IITerminated2016-11-21
Device could cause a patient overpressure situation without any visual or auditory indication or warning

FDA inspections (2)

VAI2022-04-19
Voluntary Action Indicated · Compliance: Devices · citations posted
NAI2017-06-01
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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 Northgate Technologies, 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. “Northgate Technologies Inc. (FEI 1450997) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1450997-northgate-technologies-inc/

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