Medline Industries Recalls Dialysis On/Off Kits Due to Tego Connector Seal Issues

What Happened

Medline Industries, LP has initiated a voluntary recall of specific dialysis kits following reports of issues with the silicone seals on Tego Connectors included in the kits. The affected seals may exhibit “doming” or tearing. These defects can result in an occluded fluid path, preventing users from injecting or withdrawing blood products. Additionally, damaged seals may lead to fluid leakage, therapy delays or interruptions, exposure to biological contaminants, or the infusion of air into the patient’s body.

Which Products Are Affected

The recall involves the Medline DIALYSIS ON/OFF KIT (SKU EBSI1746) containing Tego Connectors. A total of 2,020 units are affected by this recall.

Identification Details:

• UDI-DI (ea): 10653160373582
• UDI-DI (case): 00653160373585
• Affected Kit Lots: 2024051380, 2024052080, 2024052180, 2024052280, 2024071580, 2025061790, 2025072990

These products were distributed nationwide across the United States.

What You Should Do

Medline Industries, LP notified customers of the issue via a formal letter initiated on January 8, 2026. Healthcare providers and facilities should immediately check their inventory for the affected lot numbers listed above. If affected products are found, users should follow the specific instructions provided in the firm’s notification letter regarding the return or disposal of the kits.

Why This Matters

This recall is significant because defective seals in dialysis equipment can lead to serious medical complications, including the inability to perform necessary blood transfers, potential exposure to contaminants, or the life-threatening risk of air being infused into the body during treatment.

Source

Information provided by the FDA under Recall Number Z-1464-2026.