FDA (Devices) recall action 86214

Covidien, LP recalled 9 products on 2020-10-07

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2020-10-07
Critical: 0
Units: 8,100,063

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–9 of 9

SevereFDA (Devices)··2020-10-07
FDA Recalls Endo GIA Auto Suture Units Due to Staple Formation Defects
FDA is recalling Endo GIA Auto Suture Universal Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.
Product
Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Category
Distribution
0 states
HighFDA (Devices)··2020-10-07
Recall of Covidien Endo GIA Universal Loading Units Due to Staple Formation Defect
FDA is recalling specific Covidien surgical stapler kits because the staples may not form properly, potentially preventing adequate hemostasis during surgery.
Product
Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creati
Category
Distribution
0 states
HighFDA (Devices)··2020-10-07
Endo GIA Auto Suture Universal Loading Unit Recall for Staple Formation Defect
FDA is recalling Endo GIA Auto Suture Universal Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.
Product
Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Category
Distribution
0 states
HighFDA (Devices)··2020-10-07
Endo GIA Auto Suture Universal Articulating Loading Unit Recall
FDA is recalling Endo GIA Auto Suture Universal Articulating Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.
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.
Category
Distribution
0 states
SevereFDA (Devices)··2020-10-07
FDA Recalls Endo GIA Stapler Loading Units Due to Staple Formation Defect
The FDA is recalling specific lots of Endo GIA Auto Suture Universal Articulating Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.
Product
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Category
Distribution
0 states
HighFDA (Devices)··2020-10-07
Endo GIA Stapler Recall Due to Incomplete Staple Formation
FDA is recalling Endo GIA Auto Suture Universal Articulating Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.
Product
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Category
Distribution
0 states
SevereFDA (Devices)··2020-10-07
Endo GIA Stapler Recall Due to Incomplete Staple Formation
FDA recalls Endo GIA Auto Suture staplers because staples may not form properly, potentially preventing adequate hemostasis during surgery.
Product
Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Category
Distribution
0 states
HighFDA (Devices)··2020-10-07
Endo GIA Stapler Loading Units Recalled for Staple Formation Defects
FDA recalls Endo GIA Auto Suture Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.
Product
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Category
Distribution
0 states
HighFDA (Devices)··2020-10-07
Endo GIA Stapler Loading Units Recalled for Staple Formation Defects
FDA recalls Endo GIA Auto Suture Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.
Product
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Category
Distribution
0 states