Northgate Technologies, Inc.
Complete recall history across all FDA and CPSC categories — 9 total recalls
Northgate Technologies, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (9)
FDA medical device enforcement actions by Northgate Technologies, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 13, 2022 | AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe | Product labeled incorrectly. | Class II |
| Oct 25, 2021 | Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M... | The languages for Russian, Romanian, Slovak, and Czech have the power setting... | Class II |
| Jan 15, 2021 | ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Produc... | An internal tubing component in the flow path was made with incorrect materia... | Class II |
| Jan 15, 2021 | Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 71... | An internal tubing component in the flow path was made with incorrect materia... | Class II |
| Mar 10, 2020 | ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, Americ... | Investigation into a biocompatibility test discrepancy where a lot failed bio... | Class II |
| Mar 10, 2020 | AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usag... | Investigation into a biocompatibility test discrepancy where a lot failed bio... | Class II |
| Mar 10, 2020 | Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are... | As part of an investigation into a biocompatibility test discrepancy where a ... | Class II |
| May 24, 2017 | Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used wi... | The inner and outer labels on the product contain incorrect reference number ... | Class II |
| Nov 21, 2016 | Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 5... | Device could cause a patient overpressure situation without any visual or aud... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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