Elgin, IL, United States
Northgate Technologies, Inc. recalls
4 recalls recorded since 2018, most recently on 13 April 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 13 April 2022
- Terminated
- 8 November 2022
- Reason
- Product labeled incorrectly.
- Distribution
- US Nationwide distribution in the state of MA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1235-2022
- AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Ongoing Class II Medical devices
- Recall started
- 25 October 2021
- Reason
- The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
- Distribution
- US Distribution to state of MA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0333-2022
- Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.
Terminated Class II Medical devices
- Recall started
- 15 January 2021
- Terminated
- 31 October 2022
- Reason
- An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
- Distribution
- US Nationwide distribution in the states of FL and OH.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1148-2021, Z-1147-2021
- Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal
- ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the
Terminated Class II Medical devices
- Recall started
- 10 March 2020
- Terminated
- 2 February 2021
- Reason
- As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
- Distribution
- US Nationwide distribution. No governmental.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1883-2020, Z-1884-2020, Z-1885-2020
- Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
- AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
- ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.