Z-0996-2019Class II

AMSCO 5000 Series Washer/Disinfector Model # 5052

Name: Z-0996-2019 AMSCO 5000 Series Washer/Disinfector Model # 5052
Creator: Steris Corporation
Published: 2018-12-20
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2018-12-20 / Terminated / root cause: software

FDA source

Steris Corporation began a recall of AMSCO 5000 Series Washer/Disinfector Model # 5052 on 2018-12-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0996-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-20
Posted: 2019-03-09
Terminated: 2019-07-22
Recalling firm: STERIS Corporation
Product: AMSCO 5000 Series Washer/Disinfector Model # 5052
Product code: MEC Disinfector, Medical Devices
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Urgent Device Field Correction notification letters dated 12/20/18 were sent to customers.
Quantity in commerce: 68
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0996-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0995-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-08
Z-0996-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-08

Product code MEC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)