FDA Device recall Z-1885-2020
ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA)
- FDA Device
- Class II
- terminated
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA) by Northgate Technologies, citing investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1885-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-10 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Northgate Technologies |
| Distribution | US |
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
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Identifiers
| code_info | NTI Catalog Number 72-00198-0. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1885-2020%22
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