Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device Recalled by Covidien, LLC Due to Medtronic is recalling all lots of the Covidien...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Covidien, LLC directly.
Affected Products
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.
Quantity: 620 total units (260 US; 360 OUS)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 7 states: CA, IL, MN, NY, NC, OR, TN
About Covidien, LLC
Covidien, LLC has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report