Therak: THERAKOS recalls CELLEX Photopheresis Procedural Kit (product code CLXUSA) due to potential leaks that could cause illness or injury if used before full testing.
“Therakos CELLEX Photopheresis Kit Recall: Leaking Drive Tube Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61718-therakos-cellex-photopheresis-kit-recall-leaking-drive-tube-risk. Based on FDA recall #Z-0212-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0212-2022%22&limit=1).
The FDA announced on October 4, 2021, that Therakos, Inc. voluntarily recalled the THERAKOS CELLEX Photopheresis Procedural Kit because it was released before all testing was completed. If a drive tube leak occurs during use, it may cause illness or injury.
According to the FDA, the product was released prior to all testing being completed. If used and a drive tube leak were to occur, it may cause illness or injury.
Context
GovInfoNow's records show that Therakos has been subject to other recent recalls of similar products, including the Philips Integris-Allura System Recall on April 28, 2026, and the Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall on March 25, 2026. Other recent recalls of similar products include the Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall (August 10, 2026).
How to tell if you have this one
Look for the product code CLXUSA on the kit. The expiration date is February 1, 2023, and the lot number is K307.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0212-2022 (October 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0212-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.