Steris Olympus Leak Test Adapter Recall: Cleaning Solution Risk
Steris recalls Olympus Leak Test Adapter used with Acu-sInQ endoscope cleaning systems due to potential cleaning solution intrusion into endoscopes. Affected units distributed from May 2017 to June 2020.
Lower-risk recall
Potential for cleaning solution intrusion into endoscope
Contact the company
What happened, in plain English
Steris is recalling Olympus Leak Test Adapters used with Acu-sInQ endoscope cleaning systems because they might let cleaning solution leak into the endoscope. This could cause contamination or infection if not properly cleaned. Read more at govinfonow.com/recall/64114-steris-olympus-leak-test-adapter-recall-cleaning-solution-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/64114-steris-olympus-leak-test-adapter-recall-cleaning-solution-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0458-2021
Cite this page
“Steris Olympus Leak Test Adapter Recall: Cleaning Solution Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64114-steris-olympus-leak-test-adapter-recall-cleaning-solution-risk. Based on FDA recall #Z-0458-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0458-2021%22&limit=1).
Why it’s dangerous
The adapter might allow cleaning solution to leak into the endoscope during use. This could lead to contamination or infection if the endoscope isn't properly cleaned afterward.
Who’s affected
Endoscopists and medical facilities that use Olympus Leak Test Adapters with Acu-sInQ systems are likely affected. Those handling endoscopes during cleaning are at higher risk.
How to tell if you have this one
Check for part number 0600818OKN on the adapter. The product was distributed from May 23, 2017, to June 30, 2020.
- Brand
Steris- Category
Medical device
What to do — step by step
Check Adapter Part Number
Look for part number 0600818OKN on the Olympus Leak Test Adapter.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0458-2021 (October 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0458-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.