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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could prevent adequate hemostasis, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling the Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454, manufactured by Covidien, LP. The recall involves 900,007 units that were distributed worldwide, including nationwide in the United States. The product is used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
The recall is being issued because the device staples may not properly form upon application. This assembly error may result in incomplete staple formation, which can prevent adequate hemostasis (control of bleeding) during surgical procedures. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice and stop using the affected units. Consumers are not directly affected as this is a professional medical device, but patients who have had surgery using these devices should contact their healthcare provider if they have concerns about their surgical outcomes.
The recalled product
- 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.
- 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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