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 | Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. |
| Product | ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi. |
| Quantity | 1238 boxes. 3 units per box. |
| Distribution | US Nationwide distribution. No governmental. |
| Initiated | 2020-03-10 |
| Classified | 2020-05-04 |
| Terminated | 2021-02-02 |
| Recall number | Z-1885-2020 |
| 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-1885-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85204/
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