FDA DeviceClass IINotable
FDA Recall: Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Numbe
Description
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.
Hazard
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.
Remedy
5826
Related Recalls
2026-06-17 · FDA_DEVICE
FDA Recall: Allia Moveo angiographic X-ray system
GE Medical Systems, LLC
2026-06-17 · FDA_DEVICE
FDA Recall: Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
INSPIREMD Inc
2026-06-17 · FDA_DEVICE
FDA Recall: Plum Solo Precision IV Pump, 40001-0401
ICU Medical, Inc.
2026-06-17 · FDA_DEVICE
FDA Recall: Allia IGS 3 Pulse angiographic X-ray system
GE Medical Systems, LLC