The Recall Desk

Manufacturer

Therakos, Inc.

2 recalls in our database name Therakos, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2021-11-17

Of the 2 recalls from Therakos, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-0212-2022·2021-11-17

    Photopheresis Kit Recalled Due to Incomplete Testing Before Release

    Therakos is recalling 15 photopheresis kits because they were released before testing was completed. If used, a drive tube leak could cause illness or injury.

    Product
    THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1322-2016·2016-04-13

    Therakos CELLEX Photopheresis System Recalled for Tubing Leaks

    Therakos Inc is recalling 729 units of the CELLEX Photopheresis System, Lot D342, due to an increased trend in tubing leaks within the pump tubing organizer.

    Product
    The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030200003 The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treat
    Category
    Medical Device
    Distribution
    Distributed nationwide