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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70938

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 19, 2015
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

1 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 1

AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.

Z-1561-2015
Recall number
Z-1561-2015
Initiated
February 19, 2015
Classification
Class II
Status
Terminated
Recalling firm
Steris Corporation
Quantity
701 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software in select AMSCO 400 and AMSCO C units will

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a procedure delay.

Code information

AMSCO 400 Units: Serial #'s: 030051501 - 033641440; AMSCO C Units: Serial #'s: R020051501 - R023641403.

Distribution pattern

Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, I, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and, the countries of Afghanistan, Canada, Japan, Kuwait, Mexico, Republic of Korea, & United Arab Emirates.