Covidien Cytosponge Cell Collection Device Recall Due to Sponge Detachment Risk
Covidien is recalling certain Cytosponge Cell Collection Devices and Kits because the sponge may detach from the string during removal, potentially causing device fragments, obstruction, and aspiration in patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving risk-of-harm hazards (obstruction, airway obstruction, aspiration) with no reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Covidien, LLC is recalling the Cytosponge Cell Collection Device (REF: CYTO-201) and the Cytosponge Cell Collection Kit (REF: CYTO-KIT-USM). The recall was initiated because the sponge component may detach from its string during device removal from the patient.
If detachment occurs, device fragments could remain inside the patient, potentially causing obstruction, airway obstruction, or aspiration. Secondary medical interventions may be required to address retained fragments.
Approximately 6,902 units were distributed nationwide in New York, Minnesota, Virginia, and Wisconsin, as well as in Canada, the Netherlands, Poland, and the United Kingdom. Specific lot numbers are identified in the recall.
The recalled product
- Product
- Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
- Manufacturer
- Covidien, LLC
- Hazard
- sponge-detachment
- device-fragments
- airway-obstruction
- aspiration
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI/Lot: CYTO-201/20884521767789/22E1619JZX
- 22F0680JZX
- 22F0950JZX
- 22G0007JZX
- 22G0008JZX
- 22G0723JZX
- 22G0724JZX
- 22H0017JZX
- 22H0018JZX
- 22H0019JZX
- 22H0820JZX
- 22H0821JZX
- 22H1158JZX
- 22H1159JZX
- 22H1161JZX
- 22J0162JZX
- 22J0163JZX
- 22J0164JZX
- 22J1030JZX
- 22K0966JZX
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27