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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a failure to achieve hemostasis during surgery, which poses a significant risk of injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Endo GIA Auto Suture Universal Loading Units, Item Code 030457, manufactured by Covidien, LP. The recall involves 900,007 units that were distributed worldwide, including nationwide in the United States. These devices are used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and the creation of anastomosis.
The recall was initiated because the device staples may not properly form upon application. This assembly error can result in incomplete staple formation, which may prevent adequate hemostasis (the stopping of bleeding) during surgical procedures.
Healthcare providers and facilities that have received these units should stop using them and contact the recalling firm for instructions on return or replacement. Patients who have had surgery using these devices should consult their healthcare provider if they have concerns about their surgical outcome.
The recalled product
- 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.
- Manufacturer
- Covidien, LP
- Affected units
- 900,007
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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