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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82650

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

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Event summary

Timeline bucket
April 18, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Skytron, Div. The KMW Group, Inc

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

Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry

Z-1779-2019
Recall number
Z-1779-2019
Initiated
April 18, 2019
Classification
Class II
Status
Terminated
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure

Code information

Serial Numbers: 14092619, 14092620, 14102621, 17123520, 18113521

Distribution pattern

US Nationwide Distribution - AK, IA, MS