Northgate Technologies recalls
Northgate Technologies appears in 9 official U.S. recall notices indexed by RecallRadar, most recently on 2022-06-15.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 9 |
|---|---|
| Published | 2016-12-28 to 2022-06-15 |
| By agency | FDA Device (9) |
| By classification | Class II (9) |
| By status | terminated (8), ongoing (1) |
| Distribution named in notices | FL, MA, NE, TN, US |
Recalls
- AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
FDA Device · Class II · 2022-06-15 · Northgate Technologies
Reason: Product labeled incorrectly. - Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800
FDA Device · Class II · 2021-12-15 · Northgate Technologies
Reason: The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device. - ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumope…
FDA Device · Class II · 2021-03-03 · Northgate Technologies
Reason: An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. - Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention medi…
FDA Device · Class II · 2021-03-03 · Northgate Technologies
Reason: An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. - ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA)
FDA Device · Class II · 2020-05-13 · Northgate Technologies
Reason: Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. - Probe, 9 FR AUTOLITH
FDA Device · Class II · 2020-05-13 · Northgate Technologies
Reason: As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. - AUTOLITH URO-TCH 9FR PROBE 54CM
FDA Device · Class II · 2020-05-13 · Northgate Technologies
Reason: Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. - Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic li…
FDA Device · Class II · 2017-11-15 · Northgate Technologies
Reason: 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 inco… - Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas di…
FDA Device · Class II · 2016-12-28 · Northgate Technologies
Reason: Device could cause a patient overpressure situation without any visual or auditory indication or warning