# FDA recall Z-2281-2026

> **Covidien, LP** · Class II · device recall initiated 2026-04-15.

## Product

Covidien EndoStitch" Polysorb Single Use Loading Unit;  Product numbers: 170053 and 170071;

## Reason for recall

The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and  protect the product from environmental exposure.

## Distribution

Domestic: Nationwide distribution;  International: Austria, Canada, Denmark, France, Italy;

## Key facts

- **Recall number:** Z-2281-2026
- **Recalling firm:** Covidien, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-15
- **Report date:** 2026-06-10

- **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-2281-2026

## Citation

> MORVS. FDA recall Z-2281-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-2281-2026. Source: US FDA. Licensed CC0.

---

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