Steris Eagle 3000 Sterilizer Recall: Incorrect Pressure Valve Risk
Steris recalls Eagle 3000 Small Sterilizers with potential incorrect pressure safety valve in Preventive Maintenance kits. Affected units have specific serial numbers listed in the recall notice.
Lower-risk recall
Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
Contact the company
What happened, in plain English
Steris is recalling certain Eagle 3000 Small Sterilizers due to a risk that the Preventive Maintenance kit might include the wrong pressure safety valve. This could lead to improper sterilization if the valve is not correctly installed. Read more at govinfonow.com/recall/66621-steris-eagle-3000-sterilizer-recall-incorrect-pressure-valve-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/66621-steris-eagle-3000-sterilizer-recall-incorrect-pressure-valve-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0604-2020
Cite this page
“Steris Eagle 3000 Sterilizer Recall: Incorrect Pressure Valve Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/66621-steris-eagle-3000-sterilizer-recall-incorrect-pressure-valve-risk. Based on FDA recall #Z-0604-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0604-2020%22&limit=1).
Why it’s dangerous
The Preventive Maintenance kit for the 3000 Small Sterilizers might contain the incorrect pressure safety valve. If installed improperly, this could lead to inadequate sterilization of medical equipment.
Who’s affected
Healthcare facilities using the Eagle 3000 Small Sterilizer for medical equipment sterilization are most likely affected. The recall targets specific units with listed serial numbers.
How to tell if you have this one
Check the serial number on your Eagle 3000 Small Sterilizer. Affected units have specific serial numbers listed in the recall notice, including combinations starting with R81 and numbers like 100981005.
- Brand
Steris- Category
Medical device
What to do — step by step
Check Serial Number
Look for the serial number on your sterilizer to confirm if it's in the list of affected units provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 43 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL AR AZ CA CO DE FL GA HI IA ID IL IN KS LA MD ME MI MN MO MS MT NC NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV, and country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using my sterilizer immediately?
No, the recall does not require immediate discontinuation of use. Affected units should be checked against the serial number list to determine if they need action.
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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-0604-2020 (October 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0604-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.