Medline Industries Recalls Dialysis Dressing Change Kits Due to Tego Connector Seal Defects

What Happened

Medline Industries, LP has initiated a voluntary recall of specific convenience kits containing Tego Connectors. The recall was prompted by reports that the silicone seals on the Tego Connectors may exhibit issues such as doming or tearing. These defects can result in an occluded fluid path, making it impossible for users to inject or withdraw blood products with a syringe. Furthermore, damaged seals may lead to fluid leakage, therapy interruptions, exposure to biological contaminants, or the infusion of air into the patient’s body.

Which Products Are Affected

The recall involves 150 units distributed nationwide across the United States. The specific products affected are:

• Product Name: Medline DIALYSIS DRSNG CHNG (Convenience kits containing Tego Connectors)
• SKU: DYNDC3167
• UDI-DI (ea): 10195327015954
• UDI-DI (case): 40195327015955
• Affected Kit Lots: 24IME953 and 25CMA708
• Recall Number: Z-1468-2026

What You Should Do

Healthcare providers and consumers should immediately inspect their inventory for the affected kit lots (24IME953 and 25CMA708). Medline Industries, LP notified affected customers via letter starting in January 2026. If you possess any of the recalled units, you should follow the instructions provided in the firm’s notification letter regarding the return or disposal of the product. For additional information, contact Medline Industries, LP at their headquarters in Northfield, Illinois.

Why This Matters

Defective seals in dialysis equipment pose significant health risks, including the potential for air to be infused into the body or exposure to biological contaminants, both of which can lead to serious medical complications during therapy.

Source

Information provided by the FDA under recall number Z-1468-2026.