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 | Ongoing |
| Reason | The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device. |
| 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. |
| Quantity | 2,277 devices |
| Distribution | US Distribution to state of MA. |
| Initiated | 2021-10-25 |
| Classified | 2021-12-03 |
| Recall number | Z-0333-2022 |
| 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-0333-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88944/
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