# FDA recall Z-1822-2026

> **THERAKOS DEVELOPMENT LIMITED** · Class II · device recall initiated 2025-05-16.

## 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 

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1822-2026
- **Recalling firm:** THERAKOS DEVELOPMENT LIMITED
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-16
- **Report date:** 2026-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Blanchardstown, N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1822-2026

## Citation

> AI Analytics. FDA recall Z-1822-2026. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1822-2026. Source: US FDA. Licensed CC0.

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