Steris Olympus Leak Test Adapter Recall: Cleaning Solution Risk

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Recalling firmSteris Corporation5960 Heisley Rd, N/A · Mentor, OH 44060-1834

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

What to do — step by step

Check Adapter Part Number
Look for part number 0600818OKN on the Olympus Leak Test Adapter.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is for potential cleaning solution intrusion into endoscopes, which could lead to contamination or infection.

What part number should I check?

Check for part number 0600818OKN on the Olympus Leak Test Adapter.

When was this product distributed?

The product was distributed from May 23, 2017, to June 30, 2020.

Take action

Contact Steris

We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0458-2021 — Steris Steris

Hello,

I own a Steris that is covered by recall Z-0458-2021 from Steris.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Steris Corporation recalls Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible

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