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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65248

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

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Event summary

Timeline bucket
May 13, 2013
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Endologix 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

Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.

Z-1436-2013
Recall number
Z-1436-2013
Initiated
May 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
Endologix Inc
Quantity
53

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.

Code information

Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.