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 | An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. |
| 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. |
| Quantity | 45 units |
| Distribution | US Nationwide distribution in the states of FL and OH. |
| Initiated | 2021-01-15 |
| Classified | 2021-02-24 |
| Terminated | 2022-10-31 |
| Recall number | Z-1148-2021 |
| 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-1148-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87231/
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