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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92783

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

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Event summary

Timeline bucket
July 20, 2023
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

Visera Hysterovideoscope Olympus HYF Type V

Z-2480-2023
Recall number
Z-2480-2023
Initiated
July 20, 2023
Classification
Class II
Status
Ongoing
Quantity
363 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Reprocessing Controls

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.

Code information

Model HYF-V, all serial numbers

Distribution pattern

US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TX, UT, WA, and WI.