Use caution Medical device recall · FDA · Published December 20, 2018

Steris AMSCO 5000 Series Washer/Disinfector Model 5052: Software May Cause Inadequate

Steris recalls AMSCO 5000 Series Washer/Disinfector Model #5052 due to software issues that may cause medical instruments to be inadequately cleaned or disinfected. Affected units have specific serial numbers listed in the recall.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0996-2019Medical device Steris ›

Use caution until it’s fixed

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.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Steris is recalling AMSCO 5000 Series Washer/Disinfector Model #5052 because software problems might lead to medical instruments not being cleaned or disinfected properly. This could pose a risk to patient safety if instruments are used without adequate sterilization. Read more at govinfonow.com/recall/69293-steris-amsco-5000-series-washer-disinfector-model-5052-software-may.

Source Summary by GovInfoNow · govinfonow.com/recall/69293-steris-amsco-5000-series-washer-disinfector-model-5052-software-may · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0996-2019

Cite this page

“Steris AMSCO 5000 Series Washer/Disinfector Model 5052: Software May Cause Inadequate.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69293-steris-amsco-5000-series-washer-disinfector-model-5052-software-may. Based on FDA recall #Z-0996-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0996-2019%22&limit=1).

The FDA announced on Dec. 20, 2018, that Steris Corporation voluntarily recalled the AMSCO 5000 Series Washer/Disinfector Model # 5052 due to a software hazard. The agency stated the recall was initiated by the firm.

How to tell if you have it

Brand: Steris
Product: AMSCO 5000 Series Washer/Disinfector
Model #: 5052
Units affected: 68

The hazard

According to the FDA, the software in the systems may not process the cycle originally intended. This could result in damage to various medical devices and instruments or potential for inadequate cleaning or disinfection.

Context

GovInfoNow's records show Steris Corporation has 31 other recalls on record since 2017-06-15. Other recent recalls of similar products include Steris HexaVue Focus Integration System Software Issue May Cause Patient Info Mismatch (2026-09-23), Steris Corporation recalls VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006 (2026-08-31), and Steris HarmonyAIR A-Series Surgical Lights: Buttons May Detach (2026-05-15). Other recent recalls of similar products include Medline Convenience Kits: Risk of Contaminated Sterilized Products (2026-01-07), Medline Convenience Kits Recall: Risk of Contaminated Sterile Products (2026-01-07), and Medline Convenience Kits Recall: Calibration Issues May Impact Sterility (2026-01-07).

How to tell if you have this one

Check for the model number 'AMSCO 5000 Series' and serial numbers listed in the recall (e.g., 3627418005, 3601518006, etc.). The product was sold by Steris Corporation.

Brand
Steris
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
The products were distributed to the following US states: AL, AR, CA, CO, FL, GA, IL, LA, MA, MD, ME, MI, NC, NJ, NM, NY, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The products were distributed to the following foreign countries: Bahrain, Brazil, Canada, China, Saudi Arabia, South Korea, and Taiwan.

Recall number	Product, codes & lots	Quantity
Z-0995-2019	AMSCO 3000 Series Washer/Disinfector Model # 3052; Serial Numbers 3602014006 3631618006 3628818009 3629518008 3633018010 3626718010 3630918008 3630918010 3617717013 3620016019 3623516006	11
Z-0996-2019	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	68

Based on the official FDA remedy

What to do — step by step

Check Product Serial Number
Verify your unit's serial number against the list provided in the recall to confirm if it is affected.
Contact Steris for Guidance
Reach out to Steris Corporation directly for specific instructions on how to address the software issue.

Where it went and when

Where it was distributed

Distributed in 27 states, and outside the U.S.

FDA distribution: “The products were distributed to the following US states: AL, AR, CA, CO, FL, GA, IL, LA, MA, MD, ME, MI, NC, NJ, NM, NY, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The products were distributed to the following foreign countries:…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arkansas, California, Colorado, Florida, Georgia, Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 7 months after the firm started it.

Dec 20, 2018Firm started the recall
Mar 8, 2019FDA classified it Class II
Mar 20, 2019Published in FDA’s Enforcement Report
Jul 22, 2019FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/69293-steris-amsco-5000-series-washer-disinfector-model-5052-software-may">Steris AMSCO 5000 Series Washer/Disinfector Model 5052: Software May Cause Inadequate (GovInfoNow)</a>

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-0996-2019 (December 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0996-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.