Covidien Cytosponge Cell Collection Device — Class II medical device recall Z-2123-2016
Terminated recall by Covidien, LLC, reported 2016-07-13, distributed in CA, IL, MN, NC, NY, OR, TN. Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the dev
| Recall number | Z-2123-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LLC, Sunnyvale, CA, United States |
| Recall initiated | 2016-06-06 |
| Classified | 2016-07-05 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2017-10-18 |
| Distributed | CA, IL, MN, NC, NY, OR, TN |
| Countries outside the US | GB, IR |
| Reason classes | device malfunction |
| Lot numbers | F2500202X, F2500351X, F2500566X, F2500628X |
| Model numbers | CYTO-101-01 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2123-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.