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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85403

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

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Event summary

Timeline bucket
June 27, 2018
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Genicon, Inc.

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

Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.

Z-2005-2020
Recall number
Z-2005-2020
Initiated
June 27, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Genicon, Inc.
Quantity
1550

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.

Code information

Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.