Covidien, LP: Medical Device Recall in 2021 - (Recall #: Z-1385-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT

Product Classification:

Class II

Date Initiated: March 4, 2021

Date Posted: April 21, 2021

Recall Number: Z-1385-2021

Event ID: 87475

Reason for Recall:

Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.

Status: Terminated

Product Quantity: 15298 units WW: 9204 US; 6094 OUS

Code Information:

Lot Numbers: N0A0274UY N0D0037UY N0G0491UY N0K1016UY N0A0897UY N0D0391UY N0G0736UY N0L0077UY N0B0640UY N0E0175UY N0J0510UY N0M0063UY N0B0937UY N0E0802UY N0J0680UY N0M0259UY N0C0144UY N0F1055UY N0J0999UY N9K1094UY N0C0486UY N0G0185UY N0K0584UY N9L0795UY N0C1115UY N0G0250UY N0K0805UY UDI: 10884521741874 20884521741871

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated