Z-1822-2026Class II

Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA...

Name: Z-1822-2026 Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA...
Creator: Therakos Development Limited
Published: 2025-05-16
License: https://open.fda.gov/license/

Therakos Development Limited / initiated 2025-05-16 / Open, Classified / root cause: manufacturing process

FDA source

THERAKOS DEVELOPMENT LIMITED began a recall of Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product... on 2025-05-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1822-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-16
Posted: 2026-04-16
Recalling firm: Therakos Development Limited
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
Product code: LNR System, Photopheresis, Extracorporeal
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 28, 2025 MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: Determine if your facility has any of the impacted lots listed. 1. If you have received any of the kit lot numbers listed, quarantine the product and contact our Customer Care Team at 1-833-223-4ECP (1-833-223-4327) to receive instructions on how to return the affected product. 2. To report a complaint or adverse event or if you have any other questions related to the recall, please call the Customer Care Team at 1-833-223-4ECP (1-833-223-4327). Always follow the instructions for use as detailed in the Operator s Manual when installing the THERAKOS CELLEX Photopheresis System Procedural Kits. Ensuring the correct installation of the Procedural Kits is critical for system performance and avoiding treatment interruptions.
Quantity in commerce: 5826
Distribution: US Nationwide distribution.
Product codes and lots: Model/Catalog Number: CLXUSA; UDI-DI: 20705030200003; Lot Numbers: N301, N339, N340, N341, N342, N343, N344, N345, N346, N347;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1822-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1822-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-16

Product code LNR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)