Covidien EGIA 60 Curved Tip Surgical Stapler Recall for Missing Pins
FDA is recalling 3,113,280 units of the EGIA 60 Curved Tip Art Med Thick Sulu surgical stapler because missing pin components may cause incomplete staple formation and serious medical 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 in a surgical device that can lead to serious medical complications such as sepsis, peritonitis, and pneumothorax, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 3,113,280 units of the EGIA 60 Curved Tip Art Med Thick Sulu (EGIA60CTAMT) surgical stapler manufactured by Covidien LLC. The recall is classified as Class II by the agency.
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, which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax. These conditions can result in the potential for infection and/or sepsis.
The affected products were distributed nationwide domestically and worldwide foreign distribution. The specific lot codes associated with this recall are N8L0311KY and N8M0063KY. Healthcare providers and facilities should check their inventory for these specific codes and discontinue use of the affected devices.
The recalled product
- Product
- EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
- 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)
- N8L0311KY N8M0063KY
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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