Class II — THERAKOS DEVELOPMENT LIMITED
| Recalling firm | Therakos Development Limited |
|---|---|
| Registered facility | THERAKOS DEVELOPMENT LIMITED (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| 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 pho… |
| Quantity | 11,499 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2025-05-16 |
| Classified | 2026-04-16 |
| Recall number | Z-1822-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — THERAKOS DEVELOPMENT LIMITED (Z-1822-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98558/
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