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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Steris Corporation: The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.

Agency Publication Date: March 9, 2019
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Affected Products

Product: AMSCO 3000 Series Washer/Disinfector Model # 3052

Serial Numbers 3602014006 3631618006 3628818009 3629518008 3633018010 3626718010 3630918008 3630918010 3617717013 3620016019 3623516006

Product: AMSCO 5000 Series Washer/Disinfector Model # 5052

Serial Numbers 3627418005 3601518006 3612718013 3633817009 3632318011 3626718014 3625114008 3600515028 3600515029 3600515030 3628516022 3626718013 3631618008 3627418007 3624514006 3628818001 3608518007 3634517006 3630218008 3605316016 3600917004 3628218007 3628818003 3629518009 3626718009 3626718011 3627418001 3627418002 3630218012 3630218013 3630918013 3632318012 3626718016 3634517005 3631414004 3603618005 3607217008 3630318013 3626817008 3628317012 3616615026 3630918014 3633018006 3628218009 3632318009 3628218011 3623615011A 3601518012 3612817007 3627418009 3628218006 3627418008 3631618007 3617315011 3614818009 3624017008 3629215012 3614516007 3628218010 3610216025 3634313010 3611715016 3628818005 3615617008 3624017009 3616516020 3627418004 3627418006

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82035
Status: Resolved
Manufacturer: Steris Corporation
Manufactured In: United States
Units Affected: 2 products (11; 68)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.