Covidien LLC: Medical Device Recall in 2019 - (Recall #: Z-1836-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT

Product Classification:

Class II

Date Initiated: May 17, 2019

Date Posted: June 26, 2019

Recall Number: Z-1836-2019

Event ID: 82950

Reason for Recall:

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

Status: Ongoing

Product Quantity: 3,113,280

Code Information:

N6E0295UX N6H0576UX N6J1092UX N6K0230UX N6K0938UX N6L0422URX N6L0777UX N6M0607UX N7A0415UX N7C0112X N7D1013X N7E1089X N7F0275X N7F1126X N7G0444X N7H0047X N7H1067X N7J0175X N7L0825X N8A0249X N8A0655X N8B0455X N8B0945X N8C0757X N8C1213X N8D0593X N8D0907X N8E0015X N8G0648X N8J0764X N8K0823KY N8K0840Y N8L0166Y N8L0436Y N8M0845Y N9A0204Y N9B0455Y

Distribution Pattern:

Nationwide domestic distribution, worldwide foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated