Use cautionMedical device recall · FDA · Published June 2, 2023
Covidien Cytosponge Device Recall: Risk of Sponge Detaching During Use
Covidien recalls Cytosponge Cell Collection Devices and Kits with specific serial numbers due to risk of sponge detaching during removal, potentially causing airway obstruction or aspiration.
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.
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Contact the company
📍Recalling firmCovidien, LLC3062 Bunker Hill Ln · Santa Clara, CA 95054-1105
✎ GovInfoNow plain-language explainer
Covidien is recalling certain Cytosponge Cell Collection Devices and Kits because the sponge may detach from the string while being removed from a patient. This could lead to device fragments causing airway blockages or aspiration, which are serious risks during medical procedures. Read more at govinfonow.com/recall/57908-covidien-cytosponge-device-recall-risk-of-sponge-detaching-during-use.
“Covidien Cytosponge Device Recall: Risk of Sponge Detaching During Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57908-covidien-cytosponge-device-recall-risk-of-sponge-detaching-during-use. Based on FDA recall #Z-2282-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2282-2023%22&limit=1).
The FDA announced on June 2, 2023, that Covidien LLC is recalling the Cytosponge Cell Collection Device and Kit due to a risk of the sponge detaching during removal. This defect could lead to device fragments remaining in patients, causing obstruction or aspiration. Owners should stop using the products immediately.
Lot codes for REF: CYTO-KIT-USM: 22G0635JZX, 22E1624JZX, 22E1625JZX
Units affected: 6902
The hazard
The device may allow the sponge to detach from the string during removal from the patient. This could result in device fragments remaining in the patient, potentially causing obstruction, airway obstruction, supraglottic airway obstruction, or aspiration. These complications may require secondary intervention.
Context
GovInfoNow's records show Covidien LLC has 52 other recalls on record since August 7, 2017. Recent recalls include the EndoFLIP System recall from May 13, 2026, regarding catheters incorrectly flagged as expired, and the Mon-a-Therm Temperature Probe Recall from April 23, 2026, for lacking FDA clearance. Other recent recalls of similar products include the EndoStitch Polysorb Loading Unit Recall (April 15, 2026), the V-Loc 90 Wound Closure Device Recall (June 24, 2026), and the Dermalon 4-0 Blue 75cm Sutures Recall (June 24, 2026).
How to tell if you have this one
Check the device or kit for the serial numbers listed in the recall: CYTO-201/20884521767789/22E1619JZX, 22F0680JZX, and other specific codes. The recall applies to devices sold with these serial numbers.
Brand
Covidien
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Serial Numbers
Look for the serial numbers listed in the recall: CYTO-201/20884521767789/22E1619JZX, 22F0680JZX, and other specific codes.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Minnesota, New York, Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2282-2023 (June 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2282-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.