Z-0995-2019Class II

AMSCO 3000 Series Washer/Disinfector Model # 3052

Name: Z-0995-2019 AMSCO 3000 Series Washer/Disinfector Model # 3052
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 3000 Series Washer/Disinfector Model # 3052 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-0995-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-20
Posted: 2019-03-09
Terminated: 2019-07-22
Recalling firm: STERIS Corporation
Product: AMSCO 3000 Series Washer/Disinfector Model # 3052
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: 11
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 3602014006 3631618006 3628818009 3629518008 3633018010 3626718010 3630918008 3630918010 3617717013 3620016019 3623516006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0995-2019
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)