FDA recall, , Moderate risk
Cellex Photopheresis System CELLEX Photopheresis Kit
The Cellex Photopheresis Kit has increased difficulty installing the centrifuge bowl, which may dislodge and break, causing treatment delay and blood loss.
Summary by Recall Canary from the FDA notice
What happened
THERAKOS DEVELOPMENT LIMITED, of Blanchardstown, Ireland, began a recall on May 16, 2025, of the Cellex Photopheresis System, specifically the CELLEX Photopheresis Kit, due to increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder.
Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss. The recall was added to the FDA's Enforcement Report on April 16, 2026, and classified by the FDA on the same date.
The product is distributed nationwide in the US. The recall involves 11,499 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
CELLEX Photopheresis Kit
- Model number
- CLXUSA
- UDI-DI
- 20705030200003
- Lot code
- N301
- N339
- N340
- N341
- N342
- N343
- N344
- N345
- N346
- N347
- P302
- P303
- P304
- P305
- P306
- P307
- P308
- P309
- P310
- P311
- P312
- P313
- P314
- P319
- P320
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- THERAKOS DEVELOPMENT LIMITEDBlanchardstown, Ireland
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98558
- Recall number
- Z-1822-2026
- Quantity recalled
- 11,499 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
