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.
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.
The sponge may detach from the string during removal from the patient, which can cause fragments to enter the airway. This could lead to obstruction, aspiration, or the need for additional medical interventions.
Patients undergoing medical procedures using the recalled Cytosponge devices are at risk. Healthcare providers using these devices for cell collection should check if their equipment matches the listed serial numbers.
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.
Look for the serial numbers listed in the recall: CYTO-201/20884521767789/22E1619JZX, 22F0680JZX, and other specific codes.
The sponge may detach from the string during removal from the patient, which could cause device fragments to enter the airway, leading to obstruction or aspiration.
Check the device for the specific serial numbers listed in the recall. If you have the listed serial numbers, contact Covidien for guidance.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2282-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2282-2023 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
