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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79131

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

Open FDA event record

Event summary

Timeline bucket
July 13, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Pentax of America 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

Video Cystoscope models ECY-1570 and ECY-1570K

Z-0615-2018
Recall number
Z-0615-2018
Initiated
July 13, 2017
Classification
Class II
Status
Terminated
Recalling firm
Pentax of America Inc
Quantity
24

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The video cytoscopes lack 510(k) premarket notification clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The video cytoscopes lack 510(k) premarket notification clearance.

Code information

Serial number: J110097 J110101 G110053 G110051 G110052 G110054 G110015 G110084 H110086 H110088 J110062 G110016 G110039 G110048 G110049 G110038 J110061 G110021 J110078 G110056 G110057 G110073 G110037 G110058

Distribution pattern

Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.