Official recall record
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applica
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-05-16
- Country of alert
- Ireland
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 20705030200003
- Brand on record
- THERAKOS DEVELOPMENT LIMITED
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2021-10-04 · US FDA — Medical Devices
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
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