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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88981

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

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Event summary

Timeline bucket
November 02, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Olympus Corporation of the Americas

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

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V

Z-0379-2022
Recall number
Z-0379-2022
Initiated
November 02, 2021
Classification
Class II
Status
Ongoing
Quantity
14,447 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.

Code information

All serial numbers. UDI: 04953170339967

Distribution pattern

US Nationwide distribution.