Skip to content
Lower risk Medical device recall · FDA · Published December 11, 2020

Steris - Steris Corporation

Steris Corporation is a global leader in medical device manufacturing and healthcare solutions. We provide innovative products and services to improve patient care and operational efficiency in healthcare settings.

🇺🇸 FDA recall #Z-0876-2021Medical deviceSteris ›
Take action

Contact the company

Recalling firmSteris Corporation5960 Heisley Rd · Mentor, OH 44060-1834
✎ GovInfoNow plain-language explainer

What happened, in plain English

Steris Corporation is a global leader in medical device manufacturing and healthcare solutions. We provide innovative products and services to improve patient care and operational efficiency in healthcare settings. Read more at govinfonow.com/recall/63677-steris-steris-corporation.

Source Summary by GovInfoNow · govinfonow.com/recall/63677-steris-steris-corporation · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0876-2021

Cite this page

“Steris - Steris Corporation.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/63677-steris-steris-corporation. Based on FDA recall #Z-0876-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0876-2021%22&limit=1).

Why it’s dangerous

Steris products are designed for healthcare use and are not intended for consumer use. The company follows strict quality control and regulatory standards to ensure safety and efficacy.

Who’s affected

All healthcare facilities using Steris products

How to tell if you have this one

Check for the Steris logo and product labels that indicate medical use. Ensure the product is approved by relevant regulatory bodies such as the FDA.

  • Brand
    Steris
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. A

    Verify that the product is intended for medical use and has been approved by the FDA or other relevant regulatory bodies.

  2. B

    Ensure that the product is used in a healthcare setting by trained professionals following proper protocols.

  3. C

    Keep the product in a clean, dry environment to maintain its effectiveness.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Ecuador, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of Malaysia, Mexico,…” 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 18 months after the firm started it.

1. Firm started the recall: Dec 11, 202012. FDA classified it Class II: Jan 15, 202123. Published in FDA’s Enforcement Report: Jan 27, 202134. FDA terminated the recall: Jun 21, 2022420202022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What products does Steris offer?

Steris offers a wide range of medical devices, including surgical instruments, sterilization equipment, and healthcare supplies.

Similar recalls

Latest medical device recalls

Keep exploring

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-0876-2021 (December 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0876-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA