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Health product recall

ENDO GIA ULTRA UNIVERSAL STAPLER (2015-12-03)

Starting date:
December 3, 2015
Posting date:
January 7, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-56538

Affected Products

A. ENDO GIA ULTRA UNIVERSAL STAPLER

Reason

Covidien is voluntarily recalling specific item codes and production lots of Covidien Endo GIA Ultra Universal stapler handles. This voluntary recall is being conducted following customer reports of instruments failing to fire or partially firing and reports of the instrument articulating lever disengaging during use. If the instrument fails to fire or partially fires, or if the articulating lever desengages, the surgeon may be required to replace the device to continue the procedure.

Affected products

A. ENDO GIA ULTRA UNIVERSAL STAPLER

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • EGIAUSHORT
  • EGIAUSTND
  • EGIAUXL
Companies
Manufacturer

Covidien LLC

15 Hampshire Street

Mansfield

02048

Massachusetts

UNITED STATES