# FDA recall Z-2282-2023

> **Covidien, LLC** · Class II · device recall initiated 2023-06-02.

## Product

Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM

## Reason for recall

Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration.

## Distribution

Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of  Canada, Netherlands, Poland, United Kingdom.

## Key facts

- **Recall number:** Z-2282-2023
- **Recalling firm:** Covidien, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-02
- **Report date:** 2023-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Clara, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2282-2023

## Citation

> AI Analytics. FDA recall Z-2282-2023. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-2282-2023. Source: US FDA. Licensed CC0.

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