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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70858

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

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Event summary

Timeline bucket
March 26, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Olympus 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.

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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

EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

Z-2807-2015
Recall number
Z-2807-2015
Initiated
March 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
Olympus America Inc.
Quantity
6109

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.

Code information

Model: TJF-Q180V, all sold units

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.