Covidien product recalled over fire hazard

Recall date

September 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Covidien LLC recalls Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surg…

Recall number

Z-0636-2018

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

Nationally

Why it was recalled

Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.