FDA-Device2026-03-04Class IIPROCESSING DEFECT

Medline and Centurion dialysis dressing change kits recalled for defective Tego Connectors

OTHERNationwide distribution

Stop using recalled dialysis dressing kits

Medline Industries is recalling several dialysis and pheresis dressing change kits because the silicone seals on included Tego Connectors may be damaged, domed, or torn. A damaged seal can prevent blood withdrawal or injection, cause fluid leakage, delay treatment, or allow air or contaminants into the bloodstream.

  • Check your dialysis or pheresis dressing change kit against the affected SKU and lot numbers listed in the recall notice.
  • Stop using any kit with a matching SKU and lot number immediately.
  • Contact your dialysis clinic or healthcare provider for replacement kits and guidance.
  • Report any problems with these kits to the FDA MedWatch program or call 1-888-MEDLINE.
Hazard

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.

Sold states
US Nationwide distribution.
Affected count
31,848
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1467-2026

More Medline Industries, LP recalls

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief