# FDA recall Z-1228-2023

> **Covidien, LP** · Class II · device recall initiated 2023-01-25.

## Product

Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT

## 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.

## 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.

## Key facts

- **Recall number:** Z-1228-2023
- **Recalling firm:** Covidien, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-25
- **Report date:** 2023-03-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Haven, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1228-2023

## Citation

> AI Analytics. FDA recall Z-1228-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1228-2023. Source: US FDA. Licensed CC0.

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