FDA Device recall Z-2123-2016
Covidien Cytosponge Cell Collection Device
- FDA Device
- Class II
- terminated
- Published 2016-07-13
On 2016-07-13 the FDA classified a Class II recall of Covidien Cytosponge Cell Collection Device by Covidien, citing 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 pati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2123-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-06 |
| Published | 2016-07-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien |
| Distribution | CA, IL, MN, NC, NY, OR, TN |
Product
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.
Reason
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.
Identifiers
| code_info | Item Code: CYTO-101-01. Lot numbers: F2500566X, F2500628X, F2500202X, F2500351X. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2123-2016%22
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