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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68580

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

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Event summary

Timeline bucket
January 24, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cenorin, LLC

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

HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.

Z-1995-2014
Recall number
Z-1995-2014
Initiated
January 24, 2013
Classification
Class II
Status
Terminated
Recalling firm
Cenorin, LLC
Quantity
25 HLD systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.

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

The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.

Code information

610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 611001, 611002, 611004, 611101, 611102, 611103, 611201, 611202, 611203, 610902L, 611204.

Distribution pattern

Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.