# FDA recall Z-2507-2018

> **COVIDIEN MEDTRONIC** · Class II · device recall initiated 2018-05-22.

## Product

Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT

## Reason for recall

Device may be missing a sled component. The sled component is responsible for staple deployment. This  may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal  contents.

## Distribution

Nationwide U.S.A.   Internationally to: Albania, Algeria, Austria, Belgium, Bulgaria, Croatia,  Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,  Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan,  Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malta,  Martinique, Moldova, Morocco, Namibia, Netherlands, New Caledonia,  Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian federation,  Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden,  Switzerland, Tunisia, Turkey, United Arab Emirates & United Kingdom

## Key facts

- **Recall number:** Z-2507-2018
- **Recalling firm:** COVIDIEN MEDTRONIC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-05-22
- **Report date:** 2018-07-25

- **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-2507-2018

## Citation

> AI Analytics. FDA recall Z-2507-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2507-2018. Source: US FDA. Licensed CC0.

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