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

FDA device recall Z-1464-2026 · posted 2026-02-24 · Open, Classified

Recall details

Recalling firm

Medline Industries, LP

Reason for recall

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.

Action taken

On January 8, 2026, the firm notified affected customers of the product issue through email and first class mail. Customers were instructed to request stickers to over-label affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No kits are to returned.

Root cause

Process control

Status

Open, Classified

Product code

FKG

Quantity affected

2020

Distribution

US Nationwide distribution.

Date initiated

2026-01-08

Date posted

2026-02-24

Location

Northfield, IL