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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66379

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

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Event summary

Timeline bucket
September 16, 2013
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Pentax Medical Company

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

PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.

Z-0084-2014
Recall number
Z-0084-2014
Initiated
September 16, 2013
Classification
Class I
Status
Terminated
Recalling firm
Pentax Medical Company
Quantity
76 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

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Inspect official wording and provenance

Reason for recall

PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.

Code information

Model OF-B194

Distribution pattern

Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming.