Drug recall
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA…
FDA recall event 98558 · Class II · THERAKOS DEVELOPMENT LIMITED
Key facts
| Event ID | 98558 |
|---|---|
| Recall numbers | Z-1822-2026 |
| Recalling firm | THERAKOS DEVELOPMENT LIMITED |
| Product type | Devices |
| Products | Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | May 16, 2025 |
| Report date | Apr 22, 2026 |
| City | Blanchardstown |
| Country | Ireland |
| FEI number | 3036773437 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: