{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Blanchardstown",
      "state": "N/A",
      "country": "Ireland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98558",
      "recalling_firm": "THERAKOS DEVELOPMENT LIMITED",
      "address_1": "Suite 1 Plaza 211, Blanchardstown Corporate Park 2 Blanchardstown Road North",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-1822-2026",
      "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",
      "product_quantity": "5826",
      "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.",
      "recall_initiation_date": "20250516",
      "center_classification_date": "20260416",
      "report_date": "20260422",
      "code_info": "Model/Catalog Number: CLXUSA; UDI-DI: 20705030200003; Lot Numbers: N301, N339, N340, N341, N342, N343, N344, N345, N346, N347;"
    }
  ]
}