Medline Recall: Dialysis Kits with Tego Connector Seal Defects

FDA: Device Recalls Class II

Filed March 4th, 2026

Detected March 29th, 2026

Summary

The FDA has initiated a Class II recall for Medline Kits containing Tego Connectors (SKU EBSI1746) due to defects in the silicone seal, which can cause occlusion. The recall impacts nationwide distribution in the US. The recall is ongoing.

View original document View source feed page

What changed

The FDA has classified a recall of Medline Kits containing Tego Connectors (SKU EBSI1746) as Class II due to issues with the silicone seal, including doming and tearing. These defects can lead to an occluded fluid path, preventing users from injecting or withdrawing blood products with a syringe. The affected product has seen nationwide distribution within the US.

Healthcare providers and medical device manufacturers should be aware of this recall and take appropriate action regarding affected inventory. While the document does not specify a compliance deadline, the nature of a device recall necessitates immediate attention to product management and patient safety. Failure to address device defects can lead to patient harm and regulatory scrutiny.

What to do next

Review inventory for Medline DIALYSIS ON/OFF KIT (SKU EBSI1746).
Quarantine and remove affected kits from service.
Follow Medline's specific instructions for product return or disposition.

Source document (simplified)

Medline Industries, LP

Device Recalls (Class II)

← All Device Recalls (Class II) Class II Z-1464-2026 · 20260304 · Ongoing

Product

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

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....