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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72825

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

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Event summary

Timeline bucket
November 20, 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¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.

Z-0603-2016
Recall number
Z-0603-2016
Initiated
November 20, 2015
Classification
Class II
Status
Terminated
Recalling firm
Steris Corporation
Quantity
2,319 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature.

Code information

Serial #'s: 0428014026 - 0432115014

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Bahrain, Canada, China, Colombia, Costa Rica, France, Hong Kong, India, Indonesia, Israel, Kuwait, Lebanon, Mexico, Panama, Peru, Republic of Korea, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, Uganda, United Arab Emirates, Viet Nam & Virgin Islands.