Exact FDA event identifier

Event 86596

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

Open FDA event record

Event summary

Timeline bucket: October 07, 2020
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Steris Corporation

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

Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN

Z-0458-2021

Recall number: Z-0458-2021
Initiated: October 07, 2020
Classification: Class III
Status: Terminated
Recalling firm: Steris Corporation
Quantity: 293 units:248 units (USA); 45 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for cleaning solution intrusion into endoscope

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for cleaning solution intrusion into endoscope

Code information

Distributed from May 23, 2017 to June 30, 2020

Distribution pattern

Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates