Class II — Northgate Technologies, Inc.
| Recalling firm | Northgate Technologies, Inc. |
|---|---|
| Registered facility | Northgate Technologies Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Device could cause a patient overpressure situation without any visual or auditory indication or warning |
| 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 for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures |
| Quantity | 49 devices |
| Distribution | Worldwide Distribution - US including FL and MA. Internationally to Canada |
| Initiated | 2016-11-21 |
| Classified | 2016-12-21 |
| Terminated | 2017-11-27 |
| Recall number | Z-0866-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Northgate Technologies, Inc. (Z-0866-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75716/
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