Steris - Steris Corporation
Steris Corporation is a global leader in medical device manufacturing, specializing in infection control and healthcare solutions. With a focus on quality, innovation, and safety, Steris provides products and services that help healthcare facilities maintain a clean and safe environment for patients and staff.
Lower-risk recall
The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.
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What happened, in plain English
Steris Corporation is a global leader in medical device manufacturing, specializing in infection control and healthcare solutions. With a focus on quality, innovation, and safety, Steris provides products and services that help healthcare facilities maintain a clean and safe environment for patients and staff. Read more at govinfonow.com/recall/60776-steris-steris-corporation.
Source Summary by GovInfoNow · govinfonow.com/recall/60776-steris-steris-corporation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1256-2022
Cite this page
“Steris - Steris Corporation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60776-steris-steris-corporation. Based on FDA recall #Z-1256-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1256-2022%22&limit=1).
Why it’s dangerous
Steris products are designed to be safe and effective for healthcare use, with rigorous quality control and compliance standards. The risk level is low because Steris adheres to strict regulatory requirements and industry best practices.
Who’s affected
Healthcare facilities, hospitals, clinics, and medical professionals
How to tell if you have this one
Check for proper labeling, compliance with medical device regulations, and adherence to safety standards. Ensure that products are used in accordance with the manufacturer's instructions.
- Brand
Steris- Category
Medical device
What to do — step by step
1
Verify the product's regulatory status and compliance with relevant medical device regulations.
2
Ensure that the product is used in accordance with the manufacturer's instructions for use.
3
Regularly monitor the product's performance and safety to ensure it continues to meet quality standards.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide.” 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 2.5 years 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.
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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-1256-2022 (April 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1256-2022 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.