FDA Device recall Z-0458-2021
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning…
- FDA Device
- Class III
- terminated
- Published 2020-11-25
On 2020-11-25 the FDA classified a Class III recall of Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning… by Steris, citing potential for cleaning solution intrusion into endoscope.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0458-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-10-07 |
| Published | 2020-11-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Steris |
| Distribution | US |
Product
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
Reason
Potential for cleaning solution intrusion into endoscope
Identifiers
| code_info | Distributed from May 23, 2017 to June 30, 2020 |
|---|
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-0458-2021%22
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