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.
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 is classified as FDA Class II and involves a risk-of-harm product (surgical stapler) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed fatalities or Class I classification.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific lots of Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units. The recall involves 900,007 units distributed worldwide, including across the United States and globally. The affected products are identified by Lot Number 00Z2117 and Parent Code 00Z2760.
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 (control of bleeding) during surgical procedures. These staplers are used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and the creation of anastomosis.
Healthcare facilities and distributors should stop using the affected units immediately. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- 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
- Manufacturer
- Covidien, LP
- Affected units
- 900,007
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 00Z2117
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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