Recall Z-0006-2021— Covidien, LP

Name: FDA recall Z-0006-2021
Creator: U.S. Food and Drug Administration
Published: 2020-08-12

Class II · Ongoing

Class II FDA medical device recall by Covidien, LP, initiated 2020-08-12. It names one FDA 510(k) clearance: K111825. Product: Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.. Reason: The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation..

Recalling firm: Covidien, LP
Classification: Class II
Status: Ongoing
Initiated: 2020-08-12
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K111825 — ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERSCovidien, Formerly US Surgical A Divison of Tyco H·cleared 2011-10-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Reason for recall

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Data sourced from openFDA. This site is unofficial and independent of the FDA.