Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Recalled by Covidien, LLC Due to Medtronic is recalling all lots of the Covidien...

Date: June 6, 2016
Company: Covidien, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Covidien, LLC directly.

Affected Products

Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.

Quantity: 620 total units (260 US; 360 OUS)

Why Was This Recalled?

Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus.

Where Was This Sold?

This product was distributed to 7 states: CA, IL, MN, NY, NC, OR, TN

Affected (7 states)Not affected

About Covidien, LLC

Covidien, LLC has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report