FDA Device Recalls

Class IIOngoing

Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSIS CHANGE KIT SKU EBSI1453A Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741

Medline Industries, LP

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

January 8, 2026 · DeviceView details →

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;

Endo-Model Replacement Plateau; Item Number: 15-8521/15;

Endo-Model Replacement Plateau; Item Number: 15-0027/15;

Endo-Model Replacement Plateau; Item Number: 15-2835/12;

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;

Endo-Model Replacement Plateau; Item Number: 15-2836/11;

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;

Endo-Model Replacement Plateau; Item Number: 15-8521/09;

Endo-Model Replacement Plateau; Item Number: 15-8521/11;

Endo-Model Replacement Plateau; Item Number: 15-0027/12;

Endo-Model Replacement Plateau; Item Number: 15-0027/16;

FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

Diowave Laser System, REF: Diowave 250W

Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200