CELLEXRecalls & reported problems across all models

We found 4 models of CELLEX by Therakos LLC in the FDA's device registry (GUDID). Together they are named in 770 adverse event reports in the FDA's MAUDE database, received between Aug 13, 2015 and Sep 29, 2026 — classified as 4 deaths, 60 injuries, 706 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (430 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

CELLEX recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 16, 2025Open, Classified

   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.

   Z-1822-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Oct 4, 2021Open, Classified

   Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.

   Z-0212-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported CELLEX problems

CELLEX models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CELLEX CLXUSA

  SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
  2 recalls564 reports
• CELLEX CELLEXUSA

  SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
  4 deaths179 reports
• CELLEX CLXSP-I

  SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
  23 reports
• CELLEX CLXCC-I

  SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
  4 reports

Recent CELLEX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939006 ↗
• MalfunctionSep 17, 2026Fluid/Blood Leak

  The customer contacted Therakos to report they experienced a Tubing Leak with their CELLEX Photopheresis Kit ("Kit") during an Extracorporeal Photopheresis (ECP) treatment. The customer reported fluid dripping from the AC drip chamber during treatment, after 600mL of whole blood had been processed. The treatment was aborted, and the patient was reported to be stable. The customer returned a video for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803854 ↗
• MalfunctionAug 27, 2026Fluid/Blood Leak

  The customer contacted Therakos to report they experienced a Photoactivation Module Leak with their CELLEX Photopheresis Kit ("Kit") during an Extracorporeal Photopheresis (ECP) treatment. The customer reported that they received an Alarm # 8: Blood Leak? (Photoactivation Chamber) at the end of photoactivation. The customer confirmed a crack within the photoactivation module, causing a leak. The ECP treatment was aborted and the residual blood within the Kit was not returned to the patient. The customer reported the patient was in stable condition. No product was returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50474027 ↗
• MalfunctionJul 14, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25814165 ↗
• MalfunctionJun 23, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL BREAK/LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THE CENTRIFUGE BOWL BROKE AT THE BEGINNING OF THE TREATMENT. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. NO PRODUCT WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25603165 ↗
• MalfunctionJun 18, 2026Break; Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT AN ALARM # 7: BLOOD LEAK? (CENTRIFUGE CHAMBER) AND A DRIVE TUBE LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED APPROXIMATELY 1425 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER STATED THE DRIVE TUBE HAD A CIRCULAR NOTCH NEXT TO THE BEARING LOCATED NEAR THE CENTRIFUGE BOWL AND PROVIDED PHOTOS TO ILLUSTRATE.THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545724 ↗
• MalfunctionJun 18, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THAT CENTRIFUGE BOWL LEAK/BREAK OCCURRED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. APPROXIMATELY FIVE MINUTES OF TREATMENT HAD OCCURRED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. NO PICTURES WERE TAKEN, AND THE KIT WAS DISCARDED. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545548 ↗
• MalfunctionJun 11, 2026Break

  THE CUSTOMER CONTACTED THERAKOS TO REPORT A DRIVE TUBE LEAK/BREAK THAT OCCURRED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. APPROXIMATELY 1425 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE CUSTOMER DENIES ANY DIFFICULTY WITH THE CENTRIFUGE INSTALLATION. THE CUSTOMER HAS NOT RETURNED ANY PRODUCT OR PRODUCT COMPONENTS, NOR ANY PHOTOGRAPHS, FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470843 ↗
• MalfunctionJun 1, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT A PRESSURE DOME LEAK THAT OCCURRED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. LESS THAN APPROXIMATELY 100 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED EARLY, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER ALSO DESCRIBED BLOOD GETTING INTO THE PINHOLE OF THE TRANSDUCER AND INTO THE DECK. THE CUSTOMER HAS NOT RETURNED ANY PRODUCT OR PRODUCT COMPONENTS, NOR ANY PHOTOGRAPHS, FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347898 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT AN ALARM #7: BLOOD LEAK (CENTRIFUGE CHAMBER) AND A DRIVE TUBE LEAK/BREAK THAT OCCURRED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. LESS THAN APPROXIMATELY 1425 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. METAL SHAVINGS WERE NOTED IN THE BOTTOM OF THE CENTRIFUGE CHAMBER. THE CUSTOMER HAS DISCARDED THE KIT BUT HAS RETURNED PHOTOGRAPHS FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216201 ↗
• MalfunctionMay 18, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THAT AN ALARM # 57: RETURN PUMP (#3) ERROR AND A PUMP TUBING ORGANIZER (PTO) LEAK OCCURRED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. APPROXIMATELY 1050 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. TREATMENT WAS STARTING ELUTRIATION WHEN ALARM #57: RETURN PUMP (#3) ERROR OCCURRED. THE CUSTOMER RESET THE ALARM AND NOTED THE PUMP WAS NOT TURNING PROPERLY WHEN THE PUMP TUBING INSIDE THE ORGANIZER BROKE. THE CUSTOMER WAS NOT ABLE TO CLEARLY ARTICULATE WHICH SECTION BROKE. NO PICTURES WERE TAKEN, AND THE KIT WAS DISCARDED. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211879 ↗
• MalfunctionMay 12, 2026Fluid/Blood Leak; Material Twisted/Bent

  THE CUSTOMER CONTACTED THERAKOS TO REPORT AN ALARM #7: BLOOD LEAK (CENTRIFUGE CHAMBER) AND A DRIVE TUBE LEAK/BREAK, BOTH OF WHICH OCCURRED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. LESS THAN APPROXIMATELY 100 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. AFTER OPENING THE CENTRIFUGE CHAMBER DOOR, THE CUSTOMER NOTICED THE TOP OF THE DRIVE TUBE APPEARED TWISTED. THE CUSTOMER MENTIONED NO DIFFICULTIES INSTALLING THE KIT AND REPORTED A FINE MIST OF BLOOD IN A CIRCULAR MOTION ON THE WALL AND BLOOD ON THE CHAMBER CEILING. NO HOLES WERE OBSERVED. THE CUSTOMER HAS RETURNED PHOTOGRAPHS FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153477 ↗
• MalfunctionMay 6, 2026Coagulation in Device or Device Ingredient

  THE CUSTOMER CONTACTED THERAKOS TO REPORT CLOTS OBSERVED IN THE RETURN LINE WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER ALSO REPORTED ALARM #17: RETURN PRESSURE ALARMS AND OBSERVED BLOOD CLOTTING IN THE RETURN LINE WHEN APPROXIMATELY 355 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. NO PRODUCT OR PHOTOGRAPHS WILL BE RETURNED FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25103703 ↗
• MalfunctionMay 5, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A PUMP TUBING ORGANIZER (PTO) LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") OCCURRING DURING THE BLOOD PRIME PHASES OF AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THAT THE LEAK APPEARED TO BE COMING FROM THE RETURN RESERVOIR AND THAT THE PATIENT HAD NOT YET BEEN CONNECTED. THE CUSTOMER ALSO REPORTED THAT ALARM #57: RETURN PUMP (#3) ERROR ALSO OCCURRED. THE KIT HAS BEEN DISCARDED, BUT THE CUSTOMER PROVIDED PHOTOGRAPHS FOR EVALUATION. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086205 ↗
• MalfunctionMay 1, 2026Coagulation in Device or Device Ingredient

  THE CUSTOMER CONTACTED THERAKOS TO REPORT CLOTS OBSERVED IN THE RETURN LINE WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED ALARM #16: COLLECT PRESSURE AND ALARM #17: RETURN PRESSURE ALARMS AND OBSERVED BLOOD CLOTTING IN THE RETURN LINE WHEN APPROXIMATELY 470 ML OF WHOLE BLOOD HAD BEEN PROCESSED. CLOTS WERE ALSO FOUND IN THE PATIENT LINE, CENTRIFUGE BOWL, AND BLOOD FILTER. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER HAD USED THE WRONG ANTICOAGULANT (HEPARIN) CONCENTRATION - 100 U/ML INSTEAD OF 25000 U/ML. THE CUSTOMER RETURNED PHOTOS FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058217 ↗

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