Surgical staplers recalled over a malformed cover tube press
Covidien is recalling 3,263 Signia Small Diameter Curved Tip Intelligent Reloads because a manufacturing issue can allow internal components to move during firing, risking uncontrolled motion.
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: Scored 3 under the risk-of-harm criterion: uncontrolled motion during firing of a surgical stapler is a hazard, and no injuries are reported.
Plain-English summary
The Covidien Signia Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin), CFN SIGSDL45CTVT, is being recalled.
A manufacturing issue could lead to a malformed cover tube press, which can lead to internal components' movement during firing, creating the potential for uncontrolled motion.
The recall covers 3,263 units carrying UDI-DIs 20884521741840 and 10884521741843, across lots including N5F1971Y, N5F1723Y and N5D1858UY. Distribution was worldwide, including nationwide in the United States and to Austria, Belgium, Chile, Estonia, Finland and France. The FDA has classified the action as Class II.
Uncontrolled motion in a stapler during firing is a hazard to the tissue being stapled. The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Covidien's instructions.
The recalled product
- Product
- Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
- Manufacturer
- Covidien, LP
- Affected units
- 3,263
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 (7)
- CFN: SIGSDL45CTVT
- UDI-DIs: (1) 20884521741840
- (2) 10884521741843
- Lot numbers: N5F1971Y
- N5F1723Y
- N5D1858UY
- N5B1134UY
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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