Recall of Signia Tri-Staple 2.0 Reloads Due to Missing Pin Components
Covidien LLC is recalling Signia Tri-Staple 2.0 reloads 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 defect that can lead to serious medical conditions such as sepsis, peritonitis, and pneumothorax, 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 Signia Tri-Staple 2.0 Black 45mm Extra Thick Reloads (SIG45AXT) manufactured by Covidien LLC. The recall involves 3,113,280 units that were distributed nationwide and worldwide.
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 staple formation may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax, which can result in the potential for infection and/or sepsis.
Healthcare providers and facilities should stop using the affected devices and contact the recalling firm for instructions on return or replacement. The specific lot codes affected are listed in the agency's recall record.
The recalled product
- Product
- SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
- 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.
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