Covidien, LLC: Medical Device Recall in 2016 - (Recall #: Z-2123-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 6, 2016

Date Posted: July 13, 2016

Recall Number: Z-2123-2016

Event ID: 74300

Reason for Recall:

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.

Status: Terminated

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

Code Information:

Item Code: CYTO-101-01. Lot numbers: F2500566X, F2500628X, F2500202X, F2500351X.

Distribution Pattern:

Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.

Voluntary or Mandated:

Voluntary: Firm initiated