Z-2282-2023Class II

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

Name: Z-2282-2023 Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF...
Creator: Covidien, LLC
Published: 2023-06-02
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-06-02 / Open, Classified / root cause: manufacturing process

FDA source

Covidien, LLC began a recall of Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM on 2023-06-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2282-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-02
Posted: 2023-08-02
Recalling firm: Medtronic, Inc.
Product: Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Product code: EOX Esophagoscope (Flexible Or Rigid)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 6/2/23, Medtronic sent recall notices to customers who were informed of the following: 1) If product was purchased directly from Medtronic, return affected product to Medtronic. 2) If product was purchased from a distributor, return affected product to the distributor. 3) The recall notice should be passed on to all who need to be aware within your organization or to any organization where the potentially affected product has been transferred. 4) Complete and return the Customer Confirmation Form to [email protected] Adverse reactions or quality problems experienced with this product can be reported to Technical Support at [email protected] or call 1-800-448-3644 option 3.
Quantity in commerce: 6902
Distribution: Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom.
Product codes and lots: REF/UDI-DI/Lot: CYTO-201/20884521767789/22E1619JZX, 22F0680JZX, 22F0950JZX, 22G0007JZX, 22G0008JZX, 22G0723JZX, 22G0724JZX, 22H0017JZX, 22H0018JZX, 22H0019JZX, 22H0820JZX, 22H0821JZX, 22H1158JZX, 22H1159JZX, 22H1161JZX, 22J0162JZX, 22J0163JZX, 22J0164JZX, 22J1030JZX, 22K0966JZX, 22K0967JZX, 23B0301JZX, 23B0303JZX; CYTO-KIT-USM/10884521546257/22G0635JZX, 22E1624JZX, 22E1625JZX.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2282-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2282-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-02

Product code EOX

K181020Class IICytosponge Cell Collection DeviceCovidien, LLC / cleared 2018-08-16

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)