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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 6,902
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
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