FDA Recalls 3.1 Million Covidien Surgical Staplers Due to Missing Pins
The FDA is recalling 3,113,280 units of EGIA45 CT AR MD THK REL surgical staplers because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
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 involves a structural defect that can lead to serious injuries such as bleeding, anastomotic leak, 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 3,113,280 units of the EGIA45 CT AR MD THK REL (EGIA45CTAMT) surgical stapler manufactured by Covidien LLC. The recall is due to a defect where 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 serious medical complications, including bleeding, anastomotic leak, peritonitis, or pneumothorax. These conditions can further result in potential infection and/or sepsis.
The affected devices were distributed nationwide in the United States and worldwide in foreign markets. The specific code for the recalled units is N8L0401KY. Healthcare providers and facilities should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- EGIA45 CT AR MD THK REL, EGIA45CTAMT
- Manufacturer
- Covidien LLC
- Affected units
- 3,113,280
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)
- N8L0401KY
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.
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