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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82035

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 20, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Steris Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

AMSCO 3000 Series Washer/Disinfector Model # 3052

Z-0995-2019
Recall number
Z-0995-2019
Initiated
December 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
Steris Corporation
Quantity
11

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software in the systems may not process the cycle originally intended. This could result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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.

device · product 2 of 2

AMSCO 5000 Series Washer/Disinfector Model # 5052

Z-0996-2019
Recall number
Z-0996-2019
Initiated
December 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
Steris Corporation
Quantity
68

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software in the systems may not process the cycle originally intended. This could result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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.