Covidien EGIA 60 Articulating Medical Stapler Recall for Missing Pins
FDA is recalling 3,113,280 units of the EGIA 60 Articulating Medical Stapler due to missing pin components that may cause incomplete staple formation and serious surgical complications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 involves a medical device defect that can lead to serious injuries such as bleeding, anastomotic leak, peritonitis, pneumothorax, infection, and sepsis, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the EGIA 60 Articulating Medical Stapler (model EGIA60AMT) manufactured by Covidien LLC. The recall affects 3,113,280 units that were distributed nationwide and worldwide.
The recall was initiated because the device may be missing one of two pin components that maintain the alignment of the device jaws. This defect can result in incomplete staple formation during use. Incomplete stapling may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax, which can result in the potential for infection and/or sepsis.
Healthcare facilities and consumers who have this device should stop using it immediately. They should contact the manufacturer or the FDA for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
- Manufacturer
- Covidien LLC
- Affected units
- 3,113,280
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Covidien LLC 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.
See all 12 products in this recall →Related recalls
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