Recall of Cellex Photopheresis System Kits
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
THERAKOS DEVELOPMENT LIMITED is recalling 5,826 CELLEX Photopheresis Kits due to increased difficulty in installing the centrifuge bowl, which may lead to delays in treatment and blood loss.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
The recall is due to 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.
Which Products Are Affected
The affected products are the CELLEX Photopheresis Kit under the brand name Cellex Photopheresis System. The model/catalog number is CLXUSA, with UDI-DI: 20705030200003. The recall involves lot numbers: N301, N339, N340, N341, N342, N343, N344, N345, N346, N347. A total of 5,826 units are affected, distributed nationwide in the US.
What You Should Do
Consumers should contact the recalling firm, THERAKOS DEVELOPMENT LIMITED, for further instructions, as the recall was initiated via e-mail.
Why This Matters
This recall addresses potential risks that could delay medical treatments and cause blood loss, impacting patient safety in photopheresis procedures. It highlights the importance of proper device installation in medical devices.
Source
FDA recall notice Z-1822-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,156 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.