Recall archive / FDA device enforcement
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT — FDA record Z-1228-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 25, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Covidien, LP
- Quantity
- 264 US; 5056 OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1228-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI (GTIN): 20884521543598 Lots: N2D0002Y, N2D0004Y, N2D0195Y |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 15, 2023
- Recall initiation date
- Jan 25, 2023
- Center classification date
- Mar 6, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.