Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope… — Class III medical device recall Z-0458-2021
Terminated recall by Steris Corporation, reported 2020-11-25, distributed nationwide. Potential for cleaning solution intrusion into endoscope
| Recall number | Z-0458-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2020-10-07 |
| Classified | 2020-11-16 |
| Reported by FDA | 2020-11-25 |
| Terminated | 2021-07-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, GB, IT, KW |
| Model numbers | 0600818OKN |
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 for recall
Potential for cleaning solution intrusion into endoscope
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-0458-2021. 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.