Exact FDA event identifier

Event 93212

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

Open FDA event record

Event summary

Timeline bucket: October 02, 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

EVIS EXERA III Gastrointestinal Videoscope

Z-0288-2024

Recall number: Z-0288-2024
Initiated: October 02, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Olympus Corporation of the Americas
Quantity: 1687 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.

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

Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.

Code information

Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.

Distribution pattern

Nationwide Distribution.