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 | The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. Could Delay 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. |
| Quantity | 186 |
| Distribution | US Distribution to the following states : MA, NE and TN and Internationally to Canada. |
| Initiated | 2017-05-24 |
| Classified | 2017-11-08 |
| Terminated | 2020-06-09 |
| Recall number | Z-0073-2018 |
| 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-0073-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77367/
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