Z-2122-2016Class II

Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with...

Name: Z-2122-2016 Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with...
Creator: Covidien, LLC
Published: 2016-06-06
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-06-06 / Terminated / root cause: manufacturing process

FDA source

Covidien, LLC began a recall of Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology... on 2016-06-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2122-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-06
Posted: 2016-07-05
Terminated: 2017-10-18
Recalling firm: Medtronic, Inc.
Product: 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 code: EOX Esophagoscope (Flexible Or Rigid)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Medtronic, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 6, 2016 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine and discontinue use; return affected product to Medtronic/Covidien, Quality Department, 540 Oakmead Parkway, Sunnyvale CA 94085; complete and return the RECALLED PRODUCT RETURN FORM by email to Customer Service feedback.customerservice@Covidien or fax to (800)-895-6140 if product purchased directly from Medtronic; or by email to Quality Compliance [email protected] or fax to (203) 492-7719 if Product purchased through distributor or you have "no inventory"; and to promptly alert any other person or facilities if they have further distributed the product. All affected lots must be returned. If you have any questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at (800) 882-5878.
Quantity in commerce: 620 total units (260 US; 360 OUS)
Distribution: Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.
Product codes and lots: Item Code: CYTO-KIT-R; Lot numbers: 3441120915, 3441102015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2122-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2122-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-05
Z-2123-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-05

Product code EOX

K152794Class IICytosponge Cell Collection DeviceCovidien, LLC / cleared 2016-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)