Key facts
| Recalling firm | THERAKOS DEVELOPMENT LIMITED |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | 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 |
| Classification | Class II |
| Recall number | Z-1822-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| 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. |
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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 (additional items listed in FDA's full record) -- and the recall number Z-1822-2026. If it matches, stop using or distributing it and contact THERAKOS DEVELOPMENT LIMITED or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is THERAKOS DEVELOPMENT LIMITED and the affected product is described in FDA's record as: 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 (additional items listed in FDA's full record). FDA's stated reason for the recall is: 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 is tracked under FDA recall number Z-1822-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
THERAKOS DEVELOPMENT LIMITED’s FDA history
Argus HQ has recorded 1 total FDA action tied to THERAKOS DEVELOPMENT LIMITED: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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 (additional items listed in FDA's full record)) and recall number Z-1822-2026, then follow.
- Has THERAKOS DEVELOPMENT LIMITED had other FDA recalls or enforcement actions?
- This is the only FDA action Argus HQ has on file for THERAKOS DEVELOPMENT LIMITED so far. Argus ingests new FDA enforcement records daily.
- What is the FDA recall number for this event?
- FDA recall number Z-1822-2026.
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
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Related enforcement actions
Full FDA history for THERAKOS DEVELOPMENT LIMITEDCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Class II Recall: Brand Name: Cellex Photopheresis System Product Name: CELLEX… by THERAKOS DEVELOPMENT LIMITED — Recall Details. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-therakos-development-limited-z-1822-2026
"FDA Class II Recall: Brand Name: Cellex Photopheresis System Product Name: CELLEX… by THERAKOS DEVELOPMENT LIMITED — Recall Details." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-therakos-development-limited-z-1822-2026.
Argus HQ Research. "FDA Class II Recall: Brand Name: Cellex Photopheresis System Product Name: CELLEX… by THERAKOS DEVELOPMENT LIMITED — Recall Details." Digital Empire Holdings LLC. Accessed August 29, 2026. https://argushq.ai/recall/fda-recall-therakos-development-limited-z-1822-2026.
@misc{argushq_argushq_ai_recall_fda_recall_therakos_development_limited_z_1822_2026_2026,
title = {FDA Class II Recall: Brand Name: Cellex Photopheresis System Product Name: CELLEX… by THERAKOS DEVELOPMENT LIMITED — Recall Details},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/fda-recall-therakos-development-limited-z-1822-2026},
note = {Accessed: August 29, 2026}
}Source: FDA.gov — Recalls ↗