RegWardenFDA facility compliance records
Company

Northgate Technologies, Inc.

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

Recalls by year

FDA actions on record by year2016: 1 recalls; 2017: 1 recalls; 2020: 1 recalls; 2021: 2 recalls; 2022: 1 recalls1201612017201820191202022021120222023202420252026
  • Recalls (6)

Registered facilities (1)

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

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Northgate Technologies, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10092614-northgate-technologies-inc/

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