ACMI 9FR PROBE — Class II medical device recall Z-1885-2020
Terminated recall by Northgate Technologies, Inc., reported 2020-05-13, distributed nationwide. Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
| Recall number | Z-1885-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Northgate Technologies, Inc., Elgin, IL, United States |
| Recall initiated | 2020-03-10 |
| Classified | 2020-05-04 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2021-02-02 |
| Distributed | Nationwide (US) |
| Model numbers | 72-00198-0 |
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.
Reason for recall
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1885-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.