Recall archive / FDA device enforcement
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT... — FDA record Z-2282-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 2, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Covidien, LLC
- Quantity
- 6902
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2282-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Aug 9, 2023
- Recall initiation date
- Jun 2, 2023
- Center classification date
- Aug 2, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.