Covidien, LP: Medical Device Recall in 2023 - (Recall #: Z-1228-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT

Product Classification:

Class II

Date Initiated: January 25, 2023

Date Posted: March 15, 2023

Recall Number: Z-1228-2023

Event ID: 91650

Reason for Recall:

Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.

Status: Ongoing

Product Quantity: 264 US; 5056 OUS

Code Information:

UDI-DI (GTIN): 20884521543598 Lots: N2D0002Y, N2D0004Y, N2D0195Y

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington and the countries of Australia, Austria, Belgium, Canada, Canary Islands, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Caledonia, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated