Brand Name: Cellex Photopheresis System Product Name: CELLEX… — Class II medical device recall Z-1822-2026
Ongoing recall by THERAKOS DEVELOPMENT LIMITED, reported 2026-04-22, distributed nationwide. Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation
| Recall number | Z-1822-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | THERAKOS DEVELOPMENT LIMITED, Blanchardstown, N/A, Ireland |
| Recall initiated | 2025-05-16 |
| Classified | 2026-04-16 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 11,499 units |
| UPC / GTIN / UDI-DI | 20705030200003 |
| Lot numbers | 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 |
Product
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultraviolet A (UVA) light. All blood components, including the treated leukocytes, are returned to the patient. THERAKOS¿ Photopheresis utilizes the THERAKOS CELLEX System to combine cell separation and photoactivation into a single, closed and sterile circuit. The THERAKOS CELLEX Photopheresis System collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittently returns the remaining plasma and erythrocytes to the patient. The buffy coat is passed through the photoactivation module where the drug is activated with a precise amount of UVA light determined by the characteristics of the individual patient s buffy coat. After photoactivation, the buffy coat is immediately returned to the patient s bloodstream. Component: Not Applicable
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.