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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92585

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

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Event summary

Timeline bucket
June 08, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Argon Medical Devices, 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

Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797

Z-2239-2023
Recall number
Z-2239-2023
Initiated
June 08, 2023
Classification
Class II
Status
Ongoing
Quantity
3.0

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.

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

There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.

Code information

Lot: 11481383, UDI: (00)886333217151

Distribution pattern

US Nationwide distribution in the state of TX.