The Recall Desk

Manufacturer

Northgate Technologies, Inc.

9 recalls in our database name Northgate Technologies, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
1
Most recent
2022-06-15

Of the 9 recalls from Northgate Technologies, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (11%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

  • ModerateFDA (Devices)·Z-1235-2022·2022-06-15

    Biliary Electrohydraulic Lithotripter Probe Recalled for Incorrect Product Labeling

    Northgate Technologies is recalling 55 AUTOLITH Touch 1.9F biliary lithotripter probes due to incorrect product labeling. Affected devices were distributed nationwide in Massachusetts.

    Product
    AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2022·2021-12-15

    Boston Scientific AUTOLITH TOUCH lithotripter power controls reversed in four languages

    Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter devices distributed to Massachusetts have reversed high and low power settings in Russian, Romanian, Slovak, and Czech language versions. Users selecting a power level may receive the opposite setting.

    Product
    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.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1147-2021·2021-03-03

    Northgate Recalls ConMed Abdominal Insufflators Due to Incorrect Tubing Material

    Northgate Technologies is recalling 25 ConMed 50L abdominal insufflators because an internal tubing component was made with untested material.

    Product
    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 abdominal wall for visual examination of the interior or fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2021·2021-03-03

    Northgate Recalls Steris CO2MPACT Endoscopic Insufflator Systems Due to Tubing Material Error

    Northgate Technologies is recalling 45 Steris CO2MPACT Endoscopic Insufflator systems because an internal tubing component was made with incorrect, untested material.

    Product
    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 endoscope.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2020·2020-05-13

    Northgate Technologies Recalls ACMI 9FR Probes Due to Biocompatibility Failure

    Northgate Technologies is recalling ACMI 9FR probes used for stone fragmentation because a lot failed biocompatibility testing.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1884-2020·2020-05-13

    Northgate Technologies Recalls Autolith Uro-Tch 9FR Probes for Biocompatibility Failure

    Northgate Technologies is recalling Autolith Uro-Tch 9FR probes because a lot failed biocompatibility testing. The recall covers 198 boxes distributed nationwide.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1883-2020·2020-05-13

    Northgate Technologies Recalls 9 FR AUTOLITH Probes for Biocompatibility Testing Failure

    Northgate Technologies is recalling 9 FR AUTOLITH probes because a lot failed biocompatibility testing. The recall covers 298 boxes distributed nationwide.

    Product
    Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0073-2018·2017-11-15

    Northgate Electrohydraulic Lithotripter Probe Recalled for Incorrect Labeling

    Northgate Technologies is recalling 186 electrohydraulic lithotripter probes due to incorrect reference numbers on labels, which could delay patient care.

    Product
    Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0866-2017·2016-12-28

    Northgate Technologies Recalls Laparoscopic Insufflators Due to Overpressure Risk

    Northgate Technologies is recalling 49 laparoscopic insufflators because they may cause patient overpressure without visual or auditory warnings.

    Product
    Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used fo
    Category
    Medical Device
    Distribution
    2 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Northgate Technologies (United States)

company in Elgin, United States

Country
United States
Founded
1984

Official website

Source: Wikidata (Q104481275), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.