Covidien, LLC: Medical Device Recall in 2016 - (Recall #: Z-2122-2016)

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 Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies.

Product Classification:

Class II

Date Initiated: June 6, 2016

Date Posted: July 13, 2016

Recall Number: Z-2122-2016

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-KIT-R; Lot numbers: 3441120915, 3441102015

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