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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64420

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

Open FDA event record

Event summary

Timeline bucket
February 11, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Covidien LP

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

Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.

Z-1063-2013
Recall number
Z-1063-2013
Initiated
February 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Covidien LP
Quantity
6,751 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention

Code information

Lot Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.

Distribution pattern

Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.