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Northgate Technologies Recalls
9 recalls on record · December 28, 2016 to June 15, 2022 · Medical Devices
Recalls by year
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22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 15, 2022Medical DevicesFDA
Northgate Technologies, Inc. recalls AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Hazard: Product labeled incorrectly.
December 15, 2021Medical DevicesFDA
Northgate Technologies, Inc. recalls Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be us
Hazard: The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
March 3, 2021Medical DevicesFDA
Northgate Technologies, Inc. recalls Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 a
Hazard: An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
March 3, 2021Medical DevicesFDA
Northgate Technologies, Inc. recalls ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expand
Hazard: An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
May 13, 2020Medical DevicesFDA
Northgate Technologies, Inc. recalls ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - P
Hazard: Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
May 13, 2020Medical DevicesFDA
Northgate Technologies, Inc. recalls AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of
Hazard: Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
May 13, 2020Medical DevicesFDA
Northgate Technologies, Inc. recalls Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/rena
Hazard: As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
November 15, 2017Medical DevicesFDA
Northgate Technologies, Inc. recalls Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter.
Hazard: 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.
December 28, 2016Medical DevicesFDA
Northgate Technologies, Inc. recalls Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices t
Hazard: Device could cause a patient overpressure situation without any visual or auditory indication or warning