CELLEX recallZ-1822-2026 · Therakos Development Limited · initiated May 16, 2025

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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. A MEDICAL DEVICE RECALL notification dated 6/23/26 was communicated to additional consignees due to the expansion of this recall to include additional lots. Consignees are to quarantine affected product and coordinate with Therakos return of devices.

Recall details

Recall number

Z-1822-2026

Status

Open, Classified

Initiated by the company

May 16, 2025

Posted by the FDA

Apr 16, 2026

Recalling firm

Therakos Development Limited

Quantity

11,499 units

Product code

LNR

FDA submissions

P860003

Distribution

US Nationwide distribution.

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• CELLEX CLXUSA

  Therakos LLC · SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
  2 recalls564 reports

Product lines

• CELLEXTherakos LLC · 4 models · 770 reports · 2 recalls

Other devices under the same FDA submission

2 devices cleared under P860003 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• CELLEX CLXSP-I

  Therakos LLC · SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
  23 reports
• CELLEX CLXCC-I

  Therakos LLC · SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
  4 reports