# FDA recall Z-1891-2024

> **Covidien, LP** · Class II · device recall initiated 2024-04-15.

## Product

Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal,  gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis  Model: SIGTRSB60AXT

## Reason for recall

Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery

## Distribution

Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia,  Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.

## Key facts

- **Recall number:** Z-1891-2024
- **Recalling firm:** Covidien, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-15
- **Report date:** 2024-06-05

- **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-1891-2024

## Citation

> AI Analytics. FDA recall Z-1891-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1891-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*