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.
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 high-risk medical device where a defect (incomplete staple formation) poses a risk of harm (inadequate hemostasis), but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Endo GIA Auto Suture Universal Articulating Loading Units, Item Code 030452, manufactured by Covidien, LP. The recall involves 900,007 units distributed worldwide, including nationwide in the United States. The specific lot numbers affected are T0C085X, T8B048X, T8K049X, T8L087X, T9J072X, T7H002X, T8B049X, T8K095X, T9G027X, T9J099X, T7L026X, T8E063X, T8L084X, T9H043X, T9L073X, T7L027X, T8E064X, T8L085X, T9H115X, T9M016X, T8B014X, T8E075X, T8L086X, T9H116X, T9M111X, T8B015X, and T8F074X.
The recall is being issued because the device staples may not properly form upon application. This assembly error can result in incomplete staple formation, which may prevent adequate hemostasis (control of bleeding) during surgical procedures. The Endo GIA universal staplers are used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and the creation of anastomosis.
Healthcare providers and facilities that have used or possess these specific units should stop using them and contact the recalling firm, Covidien, LP, for instructions on return or replacement. Patients who have had surgery using these devices should consult their healthcare provider if they have concerns regarding their surgical outcomes.
The recalled product
- 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.
- 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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