Northgate Technologies, Inc. FDA Recalls

4 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter ProbeClass IIApr 13, 2022Product labeled incorrectly.	Product labeled incorrectly.	Class IIDevices	Apr 13, 2022
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be usClass IIOct 25, 2021The languages for Russian, Romanian, Slovak, and Czech have	The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in th	Class IIDevices	Oct 25, 2021
ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expandClass IIJan 15, 2021An internal tubing component in the flow path was made with	An internal tubing component in the flow path was made with incorrect material which was not tested for use wi	Class IIDevices	Jan 15, 2021
Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 aClass IIJan 15, 2021An internal tubing component in the flow path was made with	An internal tubing component in the flow path was made with incorrect material which was not tested for use wi	Class IIDevices	Jan 15, 2021